Senior Engineer MSAT Sterilization Validation

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

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.

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 location’s 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.