The Company
The client is the pharmaceutical division of a global FMCG, focused on transforming healthcare by advancing science to prevent, treat, and cure complex diseases. The organization drives innovation in areas such as oncology, immunology, neuroscience, and advanced therapeutics, combining cutting-edge research with strategic collaborations to deliver impactful solutions.
Role Description
As an MSAT Process Engineer you will play a key role in validating and optimizing supporting manufacturing processes for biotherapeutic drug substances. You will be part of the Supporting Process Validation team, focusing on enhancing process reliability and deploying new technologies to ensure high-quality production standards.
Responsibilities
- Leading and managing validation activities for processes such as cleaning, mixing, sterilization, and holding time.
- Defining validation strategies and contributing to change control evaluations.
- Drafting, reviewing, and approving validation documentation including protocols and reports.
- Acting as a validation lead within cross-functional project teams, providing timely updates and coordination.
- Liaising with stakeholders to schedule validation tasks and escalate issues when necessary.
- Supporting audit and inspection readiness through execution and documentation.
- Ensuring adherence to internal policies across Quality, EH&S, and business standards.
Requirements
- Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
- At least 4 years of experience in the (bio)pharmaceutical industry or equivalent academic background.
- Strong skills in communication, planning, documentation, risk analysis, and problem-solving.
- Solid understanding of regulatory frameworks and industry standards (e.g., FDA, EMA, ICH, ASTM, ISO).
- Proven experience in process validation activities (e.g., cleaning, mixing, sterilization, holding time).
- Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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