Validation Engineer, MSAT Biotherapeutics DS

Job Description:

Validation Engineer MSAT Biotherapeutics DS (Fixed Term)

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for a Validation Engineer MSAT to be based in Leiden, the Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio with the introduction of new clinical and commercial products.

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

The Validation Engineer is a member of the MSAT-SPV Team with the dedicated focus on:

• Validation of Supporting Processes used for manufacturing equipment (i.e. cleaning, mixing)
• Process improvements, benchmarking and standardization.
• New technology deployment.

Key Responsibilities:

• Assess, plan and coordinate execution of SPV activities such as qualification of cleaning, sterilization, and mixing processes.
• Support projects as a core team member responsible for qualification activities providing regular status updates in a timely manner.
• Act as subject expert matter (SME) for one or more validation categories. Leverage global MSAT network to identify and implement best practices.
• Support audits and department's perpetual audit readiness activities
• Support the site change control program by performing validation impact assessments delivering the resulting implementation plan.
• Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.).

Qualifications

Education:

• A relevant MS/MBA (i.e. (Bio)Chemical Engineering, Biotechnology) with 0-2 years of relevant experience OR bachelor’s degree with 2+ years of relevant experience (i.e. (bio)pharmaceutical industry).

Experience and Skills:

Required:

• Experience with GMP, following data integrity principles (e.g., ALCOA+) ensuring accurate documentation.
• Knowledge of validation process of equipment and related regulatory requirements and industry guidelines specific for the pharmaceutical industry (e.g. FDA, EMEA, ICH, ISPE, PDA etc.).
• Skills in effective communication, planning, documentation practices, risk management, root cause problem solving and knowledge management.
• Capability to train others within the team.

Preferred:

• Experience in validation of cleaning processes for different manufacturing systems (i.e. clean in place systems cleaning vessels/ transfer lines, equipment washers, chromatography skids and packed chromatography columns).
• 6-Sigma/Lean or similar continuous improvement methodology experience
  

Other:

• 6-Sigma/Lean or similar continuous improvement methodology experience
  

Preferred Skills:

Accelerating, Communication, Detail-Oriented, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Management Tools, Project Support, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

Hybrid Work