Qualification & Validation Specialist

About the Job:

The Qualification & Validation team, within the Quality function, provides quality oversight of system and process validation lifecycle activities, ensuring compliance with Sanofi quality standards and regulatory requirements.

Our team is responsible for quality oversight of validation activities across a broad scope, including:

Facilities, Utilities & Equipment (FUE)

Computerized Systems

Manufacturing Processes

Decontamination Methods (sterilization, cleaning, and disinfection)

Transportation

Analytical Instruments & Procedures

The team also provides quality oversight of technology transfer activities.

The Role

As a Qualification & Validation Specialist, you will be a key member of the Qualification & Validation team, serving as a trusted quality partner for validation lifecycle activities at our Singapore Tuas manufacturing site. This role is central to ensuring that our facilities, systems, and processes are qualified and validated to the highest standards – directly safeguarding the quality, safety, and efficacy of the medicines we deliver to patients.

You will work at the intersection of quality, engineering, and manufacturing – applying your technical expertise and risk-based thinking to evaluate, challenge, and approve validation activities. You will be expected to exercise sound judgment in assessing compliance with regulatory requirements and Sanofi quality standards, while collaborating closely with cross-functional teams to drive timely execution of validation deliverables.

This is a role for someone who thrives in a dynamic, regulated environment and is passionate about upholding the highest standards of pharmaceutical quality.

What You'll Do:

As a Qualification & Validation Specialist, you will play a critical role in ensuring that all qualification and validation activities meet the highest standards of quality and regulatory compliance. Your main accountabilities will include:

Quality Oversight – Provide quality oversight of qualification and validation tasks within your assigned area, ensuring all activities are executed in accordance with Sanofi standards

Documentation – Prepare and review qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices, adhering to pre-defined timelines

Deviation Management – Ensure proper documentation of deviations, non-conformances, and corrective actions

Change Control – Evaluate change controls with validation expertise to ensure quality and compliance

Regulatory Compliance – Ensure all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and Sanofi quality standards

Audit & Inspection Support – Participate in internal and external audits and health authority inspections, providing necessary documentation and expert support

Cross-functional Collaboration – Work closely with engineering, manufacturing, and quality control teams to ensure smooth execution of validation activities

Continuous Improvement – Identify opportunities to improve qualification and validation processes and contribute to ongoing improvement initiatives

About You:

Education

Bachelor's degree or higher in Science, Engineering, Pharmacy, or a related discipline

Additional certifications in Quality Management, Validation, or GMP (Good Manufacturing Practice) are advantageous

Experience

A minimum 5-7 years of experience in qualification and validation within the pharmaceutical, biotechnology, or related regulated industry

Hands-on experience with validation of: Facilities, Utilities & Equipment (FUE), computerized systems, manufacturing processes, cleaning/sterilization/disinfection methods

Experience supporting regulatory inspections and internal/external audits

Familiarity with technology transfer activities is a plus

Technical Competencies

Regulatory & Industry Standards: Sound knowledge and understanding of regulatory requirements and industry best practices (e.g., FDA, EMA, ICH, ISO, ASTM, ISPE, PDA) pertaining to management of validation lifecycle

Documentation: Proficiency in preparing and reviewing validation documentation, including Validation Master Plans, Protocols and Reports (IQ, OQ, PQ), Risk Assessments (e.g., FMEA), Traceability Matrices

Quality Risk Management: Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and their application to validation of systems.

Risk- and Science-Based Validation: Solid technical knowledge in the use and application of risk-based and science-based approaches to validation, aligned with ICH Q9 and modern validation principles

Quality Systems: Experience with deviation handling, CAPA management, and change control processes

Paperless validation Tools: Familiarity with electronic document management systems (e.g., Kneat, Veeva) is an advantage

Soft Skills

Communication: Excellent written and verbal communication skills; able to articulate complex validation concepts clearly

Collaboration: Strong team player with the ability to work effectively across functions (Engineering, Manufacturing, QC, QA)

Independence & Initiative: Able to work independently with minimal supervision while maintaining high standards of quality and compliance

Time Management: Ability to manage multiple priorities and deliver within pre-defined timelines

Continuous Improvement Mindset: Proactive in identifying opportunities to enhance validation processes and practices, and drive quality excellence

What Sets You Apart

Experience in biologics, sterile or aseptic manufacturing environments

Exposure to Health Authority inspections (e.g., HSA, FDA, EMA)

Knowledge of data integrity principles (ALCOA+)

Familiarity with Sanofi quality systems and standards

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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