843 Firmware Validation jobs in Singapore

We are looking for a Validation Engineer to support a range of qualification and validation activities across critical equipment and controlled environments. This role involves the execution of temperature mapping, equipment validation, protocol development, and performance verification to ensure compliance with regulatory standards and internal quality systems.

Key Responsibilities:

• Temperature Mapping & Environmental Qualification:
• Conduct thermal mapping studies for Cold Rooms (2°C to 8°C), Freezers, and Incubators using Kaye AVS (Advanced Validation System).
• Prepare and execute IOPQ protocols, perform data analysis, and compile comprehensive validation summary reports.

Autoclave Validation:

• Manage requalification of site autoclaves and qualification of new units, ensuring alignment with cGMP standards.
• Support introduction of new loads such as towel packs and perform specialized tests like the Air Detector Test.
• Develop and execute SOPs, OPQ protocols, and performance verification plans for all validated loads.

Equipment Validation:

• Validate and qualify Kaye Validator AVS systems through IOQ protocol development, execution, and reporting.
• Support calibration and maintenance of validation instrumentation and document performance accordingly.

Airflow Visualization Studies:

• Perform smoke studies (air visualization) for biosafety cabinets (BSCs), cleanroom zones, and equipment doors in compliance with cleanroom standards.
• Execute protocols and prepare clear and accurate documentation including study reports.

Documentation & Compliance:

• Draft validation documentation including protocols, deviation reports, and final summary reports.
• Identify and resolve discrepancies in validation findings, escalating issues as needed.
• Prepare and maintain validation maintenance reports for facility and equipment (F&E).

Requirements:

• Bachelor's Degree or Diploma in Engineering, Life Sciences, or a related technical discipline.
• Solid experience in equipment qualification, environmental validation, and temperature mapping using Kaye AVS.
• Knowledge of regulatory standards including cGMP, GDP, and GxP.
• Strong understanding of validation lifecycle: IQ, OQ, PQ, and requalification.
• Excellent technical writing, data analysis, and problem-solving skills.
• Ability to work independently and collaboratively across functional teams.

Preferred Qualifications:

• Previous experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Familiarity with cleanroom validation and environmental monitoring standards.

The Opportunity

Esco Lifesciences Group is Singapore's most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

The Scope

You will be part of Esco Aster's MSAT team and contribute to the overall site mission and objectives. You will ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner, while adhering to GxP standards. You will work with the Leadership team of MSAT to develop a continuous improvement mindset and engage in teamwork with cross-functional departments.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes.

· Develop validation protocols and reports that fulfil regulatory requirements and industry best practices.

· Assist in developing User Requirements Specification documents.

· Prepare design review and design qualification documents at the initial design stage to align with specifications.

· Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ).

· Prepare and execute FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.

· Complete assigned CQV tasks according to planned schedule, budget, safety and engineering standards.

· Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives.

· Coordinate and manage external parties, primarily vendors and contractors to achieve CQV objectives.

· Investigate deviations and write deviation reports and findings.

· Support Engineering and Facilities functions as needed.

· Undertake tasks assigned by leaders as and when appropriate.

Requirements

· Degree and/or Diploma in Engineering/Science or related studies.

· Minimum of 3-5 years' experience in pharmaceutical/biopharmaceutical manufacturing facility.

· Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.

· Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.

· Competent in technical writing and presentations.

· Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).

· Able to work independently, self-starter, self-motivated and task oriented.

· Good communication skills and able to openly communicate and escalate any relevant issues.

· Strong team player to work with both internal and external stakeholders.

· Develop positive relationship with a strong set of interpersonal skills.

· Prepared to travel and reside abroad to ensure the successful execution of external projects, if required.

Interested candidates, please submit a Cover Letter and CV to

This role is responsible for supporting validation activities including develop, support and implementation. In this role, the engineer must ensure qualification activities are performed in accordance with the company's policies and procedures, and regulatory requirements.

Responsibilities:

• Support equipment, facilities, utilities qualifications
• Develop validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and complete execution in a timely fashion,
• Manage qualification execution and lead qualification deviation investigations encountered during qualification
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
• Participate in site Validation Maintenance Program
• Support Change Implementation on site
• Any other tasks as and when assigned by supervisor / Manager
• Support other technical changes and duties as required

About You:

• Engineering/Science Degree or higher from recognised institution
• At least 2 years of experience in Equipment Qualification in the pharmaceutical/biotech industry.
• Experience in Critical Utilities, process equipment and facilities qualification is preferred.
• Must have experience in controlled temperature chamber qualification with temperature mapping.
• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
• Good Knowledge of Upstream, Downstream and Support Services equipment within the Pharma Biotech Industry.
• Good oral and written communication skills.
• Meticulous and Systematic
• Team player, with strong focus on safety, quality and timeline
• GMP/cGMP knowledge a plus
• Self-motivated and capable of working in diverse team situations with company clients and maintaining a positive attitude towards project challenges.

Duration : 09 months. Option to extend/convert subject to performance review.

Based in Tuas.

Rapsodo is a Sports Technology company with offices in the USA, Singapore, Turkey & Japan. We develop sports analytics products that are data-driven, portable and easy-to-use to empower athletes at all skill levels to analyse and improve their performance. From Major League Baseball star pitchers to Golf tour players, athletes use Rapsodo technology to up their game across the world. Trusted by coaches and players from youths to professionals, Rapsodo provides real-time insights for all-time performance. We are innovative, focused, and rapidly growing. We are continuously looking for team players who will stop at nothing to deliver state-of-the-art solutions as part of Team Rapsodo.
As a Hardware Validation Engineer, you will play a critical role in ensuring the quality and reliability of our hardware products through comprehensive testing and validation processes. You will collaborate closely with cross-functional teams, including hardware design, software development, and manufacturing, to deliver high-performance and robust solutions.
Responsibilities
Develop and execute hardware validation plans, test cases, and procedures to ensure compliance with design specifications and industry standards
Design and implement test setups, test equipment, and automation frameworks for efficient and accurate validation testing
Perform functional and performance testing of hardware components, systems, and subsystems, including but not limited to PCBs, integrated circuits, connectors, and power system
Conduct thorough analysis and troubleshooting of hardware issues, identifying root causes and proposing effective solution
Collaborate with design engineers to provide design feedback and recommendations for improvements based on validation findings
Participate in design reviews and provide input on design aspects from a validation perspective
Generate detailed test reports and documentation to communicate validation results and findings to relevant stakeholders
Stay up-to-date with industry trends, emerging technologies, and best practices related to hardware validation methodologies and tools
Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or related field
2 – 5 years of proven experience as a Hardware Validation Engineer in the consumer electronics industry or a similar role
Strong knowledge of hardware testing methodologies, tools and equipment
Solid understanding of digital and analog circuitry, signal integrity and power integrity
Proficiency in programming/scripting languages such as C/C++, Python, Perl, Bash or LabVIEW for test automation
Proven experience with lab equipment, such as oscilloscopes, logic analysers, spectrum analysers and signal generators
Familiarity with industry standards and protocols, such as MIPI CSI-2, USB, HDMI, LVDS and Ethernet
Knowledge of compliance testing and certification processes, such as FCC, CE, EMC and Safety
Experience in RF testing
Excellent problem-solving skills and the ability to analyse and debug complex hardware issues
Strong communication and teamwork skills to collaborate effectively with cross-functional and cross-cultural teams
Attention to detail and a commitment to delivering high-quality results
#J-18808-Ljbffr

Rapsodo is a Sports Technology company with offices in the USA, Singapore, Turkey & Japan. We develop sports analytics products that are data-driven, portable and easy-to-use to empower athletes at all skill levels to analyse and improve their performance. From Major League Baseball star pitchers to Golf tour players, athletes use Rapsodo technology to up their game across the world. Trusted by coaches and players from youths to professionals, Rapsodo provides real-time insights for all-time performance. We are innovative, focused, and rapidly growing. We are continuously looking for team players who will stop at nothing to deliver state-of-the-art solutions as part of Team Rapsodo.As a Hardware Validation Engineer, you will play a critical role in ensuring the quality and reliability of our hardware products through comprehensive testing and validation processes. You will collaborate closely with cross-functional teams, including hardware design, software development, and manufacturing, to deliver high-performance and robust solutions.
Responsibilities
Develop and execute hardware validation plans, test cases, and procedures to ensure compliance with design specifications and industry standards
Design and implement test setups, test equipment, and automation frameworks for efficient and accurate validation testing
Perform functional and performance testing of hardware components, systems, and subsystems, including but not limited to PCBs, integrated circuits, connectors, and power system
Conduct thorough analysis and troubleshooting of hardware issues, identifying root causes and proposing effective solution
Collaborate with design engineers to provide design feedback and recommendations for improvements based on validation findings
Participate in design reviews and provide input on design aspects from a validation perspective
Generate detailed test reports and documentation to communicate validation results and findings to relevant stakeholders
Stay up-to-date with industry trends, emerging technologies, and best practices related to hardware validation methodologies and tools
Requirements
Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or a related field
2 – 5 years of proven experience as a Hardware Validation Engineer in the consumer electronics industry or a similar role
Strong knowledge of hardware testing methodologies, tools, and equipment
Proficiency in programming languages such as C/C++, Python, or LabVIEW for test automation
Proven experience with lab equipment, such as oscilloscopes, logic analysers, spectrum analysers, and signal generators
Familiarity with industry standards and protocols, such as MIPI CSI-2, USB, HDMI, LVDS, Ethernet
Knowledge of compliance testing and certification processes, such as FCC, CE
Solid understanding of digital and analog circuitry, signal integrity, and power delivery
Excellent problem-solving skills and the ability to analyse and debug complex hardware issues
Strong communication and teamwork skills to collaborate effectively with cross-functional and cross-cultural teams
Attention to detail and a commitment to delivering high-quality results
Familiarity with scripting languages, such as Perl or Bash
#J-18808-Ljbffr

About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.
Position Overview
We are looking for a Validation Engineer to manage and execute validation activities, including equipment, utilities, and facility qualifications. You will develop and support the creation of validation documentation, apply a science-based approach to validation, analyze data, and assist with investigating deviations. Collaboration with cross-functional teams and adherence to safety, quality, and regulatory standards are key aspects of this role to ensure the successful delivery of validation projects.
Key Responsibilities
Develop, execute, and document protocols (IQ, OQ, PQ) and reports for new qualification.
Coordinate the completion of cleaning performance qualification.
Investigate and resolve discrepancies/incidents arising from qualification activities.
Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
Support change control activities, ensuring proper validation assessments and documentation.
Support other day-to-day validation activities, ensuring adherence to approved Validation SOPs, Plans, and Policies.
Work closely with End-Users, Quality, and Engineering functions to ensure validation activities are completed as planned.
Required Qualifications
Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility.
Relevant experience in validation of facility, equipment, utility, cleaning, and/or sterilization.
Familiarity with Regulatory requirements and Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
Ability to read and interpret technical documentation, system specifications, and validation protocols.
Strong analytical, problem-solving, and organizational skills.
Excellent communication skills and ability to work in a team-oriented environment.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Willingness to learn and adapt in a fast-paced, regulated industry.
Why join us?
Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
#J-18808-Ljbffr

Join to apply for the
Validation Engineer
role at
PSC Biotech Corporation .
Responsibilities include:
Process RQs (SIP, Bulk Sterilization, Autoclave)
Warehouse mapping
Filtration skids
Trending of Results
Develop, review, and approve validation lifecycle documents, protocols, and reports in accordance with policies, standards, procedures, and guidelines, completing tasks in a timely manner.
Lead validation activities and provide guidance to junior engineers.
Review Turnover/Vendor Packages to support qualification activities.
Manage qualification execution and lead deviation investigations.
Collaborate with multiple functions to plan and ensure smooth qualification activities.
Manage stakeholders and facilitate meetings related to validation activities.
Participate in site Validation Maintenance Program.
Support Change Implementation on site.
Perform other tasks as assigned by Supervisor or Project Lead.
Additional tasks include:
Utilities RQ (WFI)
Process RQs (SIP, Bulk Sterilization, Autoclave)
Cleaning validation
Warehouse mapping
Filtration skids
Mixing tank
Washer qualification
Trending of Results
Data mining
LIMS queries
Requirements
Preferably 10+ years of experience for senior role
3-5 years of experience in mid-level role
0-3 years of experience in junior role
Additional Information
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
This job posting is active and open for applications.
#J-18808-Ljbffr

The Opportunity

Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

The Scope

You will be part of Esco Aster's MSAT team and contribute to the overall site mission and objectives. You will ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner, while adhering to GxP standards. You will work with the Leadership team of MSAT to develop a continuous improvement mindset and engage in teamwork with cross-functional departments.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes.

· Develop validation protocols and reports that fulfil regulatory requirements and industry best practices.

· Assist in developing User Requirements Specification documents.

· Prepare design review and design qualification documents at the initial design stage to align with specifications.

· Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ).

· Prepare and execute FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.

· Complete assigned CQV tasks according to planned schedule, budget, safety and engineering standards.

· Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives.

· Coordinate and manage external parties, primarily vendors and contractors to achieve CQV objectives.

· Investigate deviations and write deviation reports and findings.

· Support Engineering and Facilities functions as needed.

· Undertake tasks assigned by leaders as and when appropriate.

Requirements

· Degree and/or Diploma in Engineering/Science or related studies.

· Minimum of 1-3 years’ experience in pharmaceutical/biopharmaceutical manufacturing facility.

· Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.

· Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.

· Competent in technical writing and presentations.

· Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).

· Able to work independently, self-starter, self-motivated and task oriented.

· Good communication skills and able to openly communicate and escalate any relevant issues.

· Strong team player to work with both internal and external stakeholders.

· Develop positive relationship with a strong set of interpersonal skills.

· Prepared to travel and reside abroad to ensure the successful execution of external projects, if required.

Interested candidates, please submit a Cover Letter and CV to

The Opportunity

Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

The Scope

You will be part of Esco Aster's MSAT team and contribute to the overall site mission and objectives. You will ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner, while adhering to GxP standards. You will work with the Leadership team of MSAT to develop a continuous improvement mindset and engage in teamwork with cross-functional departments.

Primary work location: Ayer Rajah Crescent, Singapore

Job Responsibilities

· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes.

· Develop validation protocols and reports that fulfil regulatory requirements and industry best practices.

· Assist in developing User Requirements Specification documents.

· Prepare design review and design qualification documents at the initial design stage to align with specifications.

· Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ).

· Prepare and execute FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.

· Complete assigned CQV tasks according to planned schedule, budget, safety and engineering standards.

· Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives.

· Coordinate and manage external parties, primarily vendors and contractors to achieve CQV objectives.

· Investigate deviations and write deviation reports and findings.

· Support Engineering and Facilities functions as needed.

· Undertake tasks assigned by leaders as and when appropriate.

Requirements

· Degree and/or Diploma in Engineering/Science or related studies.

· Minimum of 3-5 years’ experience in pharmaceutical/biopharmaceutical manufacturing facility.

· Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.

· Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.

· Competent in technical writing and presentations.

· Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).

· Able to work independently, self-starter, self-motivated and task oriented.

· Good communication skills and able to openly communicate and escalate any relevant issues.

· Strong team player to work with both internal and external stakeholders.

· Develop positive relationship with a strong set of interpersonal skills.

· Prepared to travel and reside abroad to ensure the successful execution of external projects, if required.

Interested candidates, please submit a Cover Letter and CV to