912 Process Validation jobs in Singapore

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

We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer with over 8 years in the pharmaceutical and cGMP industry.

• Lead and participate in Engineering, Procurement, Construction, Validation for GMP facilities.
• Prepare, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
• Conduct root cause analysis and lead quality investigations (deviations, CAPA, change control).
• Manage validation schedules and resource alignment.
• Support manufacturing process setup and technical activities.
• Perform FAT/SAT activities and temperature mapping.
• Utilize Delta V, Kneat, Veeva, and Trackwise.

• 8+ years CQV experience in pharma/cGMP.
• Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.
• Proven problem-solving and project coordination skills.
• Excellent communication abilities.
• Bachelor of Science in Chemical/Biological Engineering or related field.

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.

Position: Validation Engineer

We are Coalesce Management Consulting - a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

We are currently expanding our team and are looking for a Validation Engineer to support projects on-site with a client.

Key Responsibilities:

• Prepare and execute validation protocols (URS, IOQ, PQ, FMEA, PVP) for equipment such as CIP tanks, robotic cleaners, and utility systems
• Conduct cleaning validation, temperature mapping, and requalification activities
• Ensure timely delivery of validation documentation and compliance with project timelines
• Develop and review qualification documentation (DQ, IQ, OQ, PQ, SAT, QSR) in both paper-based and digital platforms (KNEAT)
• Support validation of chemical production systems and cleanroom equipment
• Coordinate equipment change releases and ensure timely CR closures

Requirements:

• Degree related to Science or Engineering.
• Good knowledge and experience in GMP facilities.
• At least 5 years of experience in manufacturing, and biopharmaceutical industries.
• Ability to multitask and work in a fast-paced environment with competing priorities.
• Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels.
• Exhibit continuous improvement mindset and innovative thinking

What's in it for you?

• Greatest exposure to the Big Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

If you are interested in applying for this position, please send an email to

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.

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.

Position: Validation Engineer

We are Coalesce Management Consulting - a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

We are currently expanding our team and are looking for a Validation Engineer to support projects on-site with a client.

Key Responsibilities:

• Prepare and execute validation protocols (URS, IOQ, PQ, FMEA, PVP) for equipment such as CIP tanks, robotic cleaners, and utility systems
• Conduct cleaning validation, temperature mapping, and requalification activities
• Ensure timely delivery of validation documentation and compliance with project timelines
• Develop and review qualification documentation (DQ, IQ, OQ, PQ, SAT, QSR) in both paper-based and digital platforms (KNEAT)
• Support validation of chemical production systems and cleanroom equipment
• Coordinate equipment change releases and ensure timely CR closures

Requirements:

• Degree related to Science or Engineering.
• Good knowledge and experience in GMP facilities.
• At least 5 years of experience in manufacturing, and biopharmaceutical industries.
• Ability to multitask and work in a fast-paced environment with competing priorities.
• Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels.
• Exhibit continuous improvement mindset and innovative thinking

What’s in it for you?

• Greatest exposure to the Big Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

If you are interested in applying for this position, please send an email to

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.

We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer with over 8 years in the pharmaceutical and cGMP industry.

• Lead and participate in Engineering, Procurement, Construction, Validation for GMP facilities.
• Prepare, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
• Conduct root cause analysis and lead quality investigations (deviations, CAPA, change control).
• Manage validation schedules and resource alignment.
• Support manufacturing process setup and technical activities.
• Perform FAT/SAT activities and temperature mapping .
• Utilize Delta V, Kneat, Veeva, and Trackwise .

• 8+ years CQV experience in pharma/cGMP.
• Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE .
• Proven problem-solving and project coordination skills .
• Excellent communication abilities .
• Bachelor of Science in Chemical/Biological Engineering or related field.

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