Engineer MSAT LM Validation

Job Description:

Validation Engineer MSAT Biotherapeutics Drug Substance (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 (e.g. mixing validation, buffer and microbial hold time, sterilization).
• Process improvements, benchmarking and standardization.
• New technology deployment.

Key Responsibilities:

• Assess, plan and coordinate execution of SPV activities such as qualification of mixing, buffer hold time, microbial hold time and sterilization 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 inspections 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 (e.g. (Bio)Chemical Engineering, Biotechnology) with 0-2 years of relevant experience OR bachelor’s degree with 2+ years of relevant experience.
  

Experience and Skills:

Required:

• Relevant experience in the (bio)pharmaceutical industry or related academic experience or education.
• Experience with GMP, following data integrity principles (e.g., ALCOA+) ensuring proper 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 mentor and train others within the team.

Preferred:

• Experience in mixing validation, buffer and microbial hold time, sterilization (moist heat) qualification.
• 6-Sigma/Lean or similar continuous improvement methodology experience.

Other:

• Language: English proficiency required; Dutch is a plus.

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 wo