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 Senior Engineer is a member of the MSAT Supporting Process Validation (SPV) Team with the dedicated focus on: Validation of supporting processes (e.g., cleaning, mixing, sterilization, holding time); Process improvements, benchmarking, and standardization,New technology deployment.

Lead, plan, coordinate, and execute validation activities such as cleaning validation, mixing validation, sterilization qualification, and holding time studies.
Support definition of validation strategy and change control assessments.
Write, review and approve 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).

Functie-eisen

Bachelor’s or master’s degree or equivalent in Science, Engineering or Technical subject.
Minimum 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education is required.
Skills in communication, planning, good documentation practices, risk management, root cause problem solving and knowledge management.
6-Sigma/Lean or similar continuous improvement methodology experience.
Understanding of regulatory requirements and industry guidelines specific to the pharmaceutical industry and validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).
Experience in qualification and validation (e.g., cleaning validation, mixing validation, sterilization qualification, holding time studies).

Arbeidsvoorwaarden

At Janssen Biologics, you'll be part of a global market leader and a highly motivated team that is passionate about its work. We are committed to fostering your personal and professional growth with opportunities to work on exciting projects and assignments.

Flexible working hours.
Excellent benefits and competitive compensation.
A dynamic and inspiring work environment.
Continuous professional development and educational opportunities.
The chance to make a real impact on the lives of patients.
Duration: 12-month contract
Hours: 40 hours per week
Work Model: Hybrid (3 days on-site)

Bedrijfsinformatie

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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