Senior Process Validation Engineer MSAT

Auris Health

Auris Health

2440 Geel, Belgium
Posted on Thursday, August 31, 2023
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The Chemical Production facility in Geel (Belgium) is the largest manufacturing site of Small Molecule Active Pharmaceutical Ingredients (SM API) and Drug Product Intermediates (DPI) in Johnson & Johnson. Furthermore, it is the Launch & Grow site for new SM API and DPI in our Janssen Supply Chain!

Within the Manufacturing Science and Technology (MSAT) organization in Geel, we have a vacancy for Process Validation Engineer (unlimited duration) . In this role, you have a focus on Life Cycle Process Validation (LCPV) and on Real-Time-Release applications in manufacturing.

Key Responsibilities:

  • Lead process validation activities for NPI and commercial products, in close collaboration with planning department, technical launch integrator, process engineer, production department, quality assurance and quality control:

    • set up Process Performance Qualification (PPQ) plans for new PPQ-studies preserving production feasibility and efficiency

    • develop statistical or risk-based sampling plans, interpret test results, and perform statistical evaluations

    • draw up and maintain Validation Master Plan and other validation documents

  • Lead the execution of Life Cycle Process Validation:

    • perform gate keeping of proposed changes, assess impact, and complete LCPV actions as assigned

    • prepare and update LCPV documents, procedures and maintain related database

    • train new co-workers in LCPV work process and maintain the training

  • Be a domain authority for Real-Time-Release models in manufacturing by supervising and trending model performance, giving local support to end-users, assessing change controls with potential impact on RTR, participating in testing and hypercare meetings for new or updated models, being the spokesperson for RTR in audits, and providing recommendations for the RTR app roadmap

  • Be the system owner and spokesperson for LCPV at audits/regulatory inspections, and follow-up on LPCV Key Performance Indicators

  • Be the domain authority for LCPV Geel as member or lead in local and global teams e.g. SM API LCPV Community of Practice

  • Be the Janssen Point of Contact for third parties working on LCPV and CPV, and follow-up and track deliverables and performance

  • Reduce deviations and continuously improve the process validation and RTR work processes according to standards of quality, safety, health, environment and cost

  • Apply ‘Management of Change’ principles for optimizations and changes

  • Build up and demonstrate excellent expertise in process validation and RTR work processes, and profound knowledge of the equipment, production environment, and process management systems, supporting MSAT knowledge building and the site mission as Launch & Growth Site



  • Master’s Degree (University) preferred within bioscience engineering, chemical engineering, chemistry, biomedical sciences, or pharmacy with minimum 5 years work experience in life sciences manufacturing

  • Certified or willing to be trained/certified as statistical subject matter expert

Experience and Skills:

  • Experience in process validation, real-time-release applications, and/or Small Molecule API manufacturing is highly valued

  • Combining scientific and administrative accuracy with good social skills

  • Strong quality mentality with knowledge of Quality & Compliance and GMP/regulatory requirements

  • Ability to work under pressure, handling conflicting interests, having a good sense of prioritization of tasks, and handling time accordingly

  • Highly team-oriented, able to interact at different levels of the organization

  • Proficient in Dutch and English (spoken and written)

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.