Senior Engineer MSAT Validation

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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 Bachelors 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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.