Senior Engineer MSAT Validation

Job Description:

Senior Engineer MSAT Validation - Biotherapeutics Drug Substance

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Engineer MSAT Validation 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 Senior Engineer MSAT Validation is a member of the MSAT SPV (Supporting Process Validation) team with the dedicated focus on:

• Validation of supporting processes (e.g. sterilization, mixing validation, buffer and microbial hold time).
• Process improvements, benchmarking and standardization.New technology deployment.

Key Responsibilities:

• Lead the execution of validation activities such as sterilization (moist heat) performance qualification.
• Write and review validation plans, protocols and reports.
• Act as project core team member responsible for performance qualification activities:
• Defining validation strategy.
• Representing MSAT in multidisciplinary team and aligning with extended team members.
• Planning and delivering team and project goals and objectives.
• Communicating with stakeholders, managing timelines, providing project status update and escalating issues.
• Defining validation strategy.
• Participate in preparation and represent MSAT as SME in audits and inspections
• Perform change control assessments and execute against assigned actions.
• Act as coach for more junior engineers.
• Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.)

Qualifications

Education

A relevant MS/MBA/Ph.D. degree (e.g. Science, Engineering, Biotechnology) or equivalent with minimum of 2 years of relevant experience OR Bachelor’s degree (e.g. Science, Engineering, Biotechnology) with minimum of 4 years of relevant experience in the (bio)pharmaceutical industry.

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.
• Experience in performance qualifications of equipment and related regulatory requirements and industry guidelines specific to the pharmaceutical industry (e.g. FDA, EMA, WHO, ISO, ICH, ISPE, PDA).
• Experience in sterilization (moist heat) qualification.
• Skills in technical writing and documentation practices, effective communication, planning, risk management, root cause problem solving, knowledge management and stakeholder management.
• Capability to coach and train others within the team.

Preferred

• Experience in audits and inspections (e.g. IGJ, FDA).
• 6-Sigma/Lean or similar continuous improvement methodology experience.

Other

Language: English proficiency required; Dutch is a plus.

Hybrid Work