Engineer MSAT Validation

Engineer MSAT Validation

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for an Engineer MSAT to be based in Leiden, the Netherlands. Our site produces biotherapeutic drug substances and is growing our portfolio.

The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership and key driver of sophisticated technologies to enable the best value for patients.

The Engineer is a member of the MSAT Supporting Process Validation (SPV) Team with the dedicated focus on:

1. Validation of supporting processes (e.g., cleaning, mixing, sterilization, holding time).
2. Process improvements, benchmarking, and standardization.
3. New technology deployment.

Job Duties and Responsibilities

• Plan, coordinate, and execute manufacturing equipment validation activities such as cleaning validation, mixing validation, and hold time studies.
• Write and review validation protocols and reports.
• Support projects as extended project team member responsible for validation activities providing regular status updates in a timely manner.
• Communicate with stakeholders to coordinate timing of execution and escalate issues.
• Support execution of activities for audit/inspection readiness.
• Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo).

Minimum Qualification and Requirements

• Bachelor's degree or equivalent in Science, Engineering or Technical subject.
• Minimum 2 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Skills in communication, planning, documentation practices, risk management, root cause problem solving and knowledge management.
• Understanding of regulatory requirements and industry guidelines specific to the pharmaceutical industry and validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA)

Preferred:

• Experience in validation of manufacturing (e.g. cleaning process, mixing process, microbial/chemical holding time)
• 6-sigma/Lean or similar continious improvement methodology experience

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