736 Technical Assurance jobs in Singapore

• Manage Computer System Validation Lifecycle from design to execution phases.
• Work with QA and stakeholders to develop the CSV strategy.
• Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols.
• Responsible for test case execution, deviation handling, and drafting of system SOPs.
• Any other task assigned by Supervisor/Manager.

• Bachelor Degree in a scientific or related engineering discipline with at least 5 years' experiences in CSV QA validation.
• Good understanding of DeltaV coding and configuration in order to support CSV protocol generation and review for DeltaV processes.
• Knowledge of validation lifecycle, current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP).
• Familiar with Health Authorities standards (e.g. FDA CFR and EU)
• Must be team player, curious with strong analytical and organizational skills

• Duration : 09 months.
• Based in Tuas.

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking for a Computer System Validation Engineer with experience in pharmaceutical engineering for a role in Singapore.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience in bioprocess systems, or other process equipment, utilities, facilities in pharma, biologics, aseptic fill-finish is considered a strong asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Visit construction and installation sites.
• Supervise contractors during critical testing of system and equipment.
• Other duties as assigned by client, and/or PharmEng, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 5+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects.
• Knowledge of GAMP and Data Integrity requirements.
• Previous Pharmaceutical/Biotech experience is mandatory for this role.
• Experience with Qualification or Validation of clean utilities
• Experience with thermal Validation is considered an asset.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering or Science degree, preferably in Automation, Instrumentation, Mechanical, Electrical, Electromechanical, Chemical, Biochemical or a related discipline.
• Ability to lift 50 lbs.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone's unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

EEOC Statement

At PharmEng Technology, we don't just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking for a Computer System Validation Engineer with experience in pharmaceutical engineering for a role in Singapore.
Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
Experience in bioprocess systems, or other process equipment, utilities, facilities in pharma, biologics, aseptic fill-finish is considered a strong asset.
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
Engage other departments, as required, for design reviews and decisions.
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
Visit construction and installation sites.
Supervise contractors during critical testing of system and equipment.
Other duties as assigned by client, and/or PharmEng, based on workload and project requirements.
Qualifications
Excellent written and spoken English is required including the preparation of technical documents in English
Years of experience: 5+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
Experience with developing and executing validation projects.
Knowledge of GAMP and Data Integrity requirements.
Previous Pharmaceutical/Biotech experience is mandatory for this role.
Experience with Qualification or Validation of clean utilities
Experience with thermal Validation is considered an asset.
Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
Possess mentorship skills, to coach and develop junior and intermediate employees.
Engineering or Science degree, preferably in Automation, Instrumentation, Mechanical, Electrical, Electromechanical, Chemical, Biochemical or a related discipline.
Ability to lift 50 lbs.
Travel may be required on occasion.
Ability to handle multiple projects and work in a fast-paced environment.
Strong multi-tasking skills
Why PharmEng Technology?
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.
EEOC Statement
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
#J-18808-Ljbffr

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking for a Computer System Validation Engineer with experience in pharmaceutical engineering for a role in Singapore.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience in bioprocess systems, or other process equipment, utilities, facilities in pharma, biologics, aseptic fill-finish is considered a strong asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Visit construction and installation sites.
• Supervise contractors during critical testing of system and equipment.
• Other duties as assigned by client, and/or PharmEng, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 5+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects.
• Knowledge of GAMP and Data Integrity requirements.
• Previous Pharmaceutical/Biotech experience is mandatory for this role.
• Experience with Qualification or Validation of clean utilities
• Experience with thermal Validation is considered an asset.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering or Science degree, preferably in Automation, Instrumentation, Mechanical, Electrical, Electromechanical, Chemical, Biochemical or a related discipline.
• Ability to lift 50 lbs.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus Facility. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two Modulus facilities is constructed in Singapore at a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.

As an Expert II, (Computerized Systems Validation) QA you are to ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system (EMS), laboratory information management system (LIMS), batch record management systems (MES), Data Historian), Process Control Systems (e.g., distributed control system (DCS), programmable logic controller (PLC)), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems. You will support the establishment and maintenance of site’s computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.

Key Accountabilities

• Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.

• Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.

• Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.

• Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.

• Author CSV plans and procedures.

• Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.

• Ensure continual improvement of CSV program by performing periodic review of the program.

• Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.

• Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.

• Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.

• Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.

About You

Education and experience

• Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.

• A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.

Key technical competencies and soft skills:

• Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.

• Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.

• Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.

• Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.

• Good communication skills to present validation strategies to the site management and other functions.

• Experience in greenfield/brownfield facilitystart-upswill be advantageous .

• Familiar with Digital 4.0 concepts and potential applications in Quality.

• Able to work independently with little supervision.

• Experience with ensuring Data Integrity in computerized systems.

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus Facility. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two Modulus facilities is constructed in Singapore at a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.

As an Expert II, (Computerized Systems Validation) QA you are to ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system (EMS), laboratory information management system (LIMS), batch record management systems (MES), Data Historian), Process Control Systems (e.g., distributed control system (DCS), programmable logic controller (PLC)), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems. You will support the establishment and maintenance of site’s computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.

Key Accountabilities

• Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.

• Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.

• Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.

• Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.

• Author CSV plans and procedures.

• Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.

• Ensure continual improvement of CSV program by performing periodic review of the program.

• Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.

• Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.

• Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.

• Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.

About You

Education and experience

• Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.

• A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.

Key technical competencies and soft skills:

• Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.

• Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.

• Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.

• Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.

• Good communication skills to present validation strategies to the site management and other functions.

• Experience in greenfield/brownfield facilitystart-upswill be advantageous .

• Familiar with Digital 4.0 concepts and potential applications in Quality.

• Able to work independently with little supervision.

• Experience with ensuring Data Integrity in computerized systems.

About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus Facility. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two Modulus facilities is constructed in Singapore at a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.
As an
Expert II, (Computerized Systems Validation) QA
you are to ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system (EMS), laboratory information management system (LIMS), batch record management systems (MES), Data Historian), Process Control Systems (e.g., distributed control system (DCS), programmable logic controller (PLC)), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems. You will support the establishment and maintenance of site’s computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.
Key Accountabilities
Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.
Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.
Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.
Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.
Author CSV plans and procedures.
Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.
Ensure continual improvement of CSV program by performing periodic review of the program.
Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.
Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.
Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.
Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.
About You
Education and experience
Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
Key technical competencies and soft skills:
Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.
Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.
Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.
Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
Good communication skills to present validation strategies to the site management and other functions.
Experience in greenfield/brownfield facilitystart-upswill be advantageous .
Familiar with Digital 4.0 concepts and potential applications in Quality.
Able to work independently with little supervision.
Experience with ensuring Data Integrity in computerized systems.
#J-18808-Ljbffr

About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus Facility. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two Modulus facilities is constructed in Singapore at a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.
As an
Expert II, (Computerized Systems Validation) QA
you are to ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system (EMS), laboratory information management system (LIMS), batch record management systems (MES), Data Historian), Process Control Systems (e.g., distributed control system (DCS), programmable logic controller (PLC)), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems. You will support the establishment and maintenance of site’s computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.
Key Accountabilities
Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.
Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.
Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.
Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.
Author CSV plans and procedures.
Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.
Ensure continual improvement of CSV program by performing periodic review of the program.
Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.
Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.
Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.
Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.
About You
Education and experience
Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
Key technical competencies and soft skills:
Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.
Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.
Solid technical knowledge
in the use and application of risk- and science-based approaches to CSV.
Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
Good communication skills to present validation strategies to the site management and other functions.
Experience in greenfield/brownfield facility start-ups will be advantageous .
Familiar with Digital 4.0 concepts and potential applications in Quality.
Able to work independently with little supervision.
Experience with ensuring Data Integrity in computerized systems.
#J-18808-Ljbffr