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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.

Drug Product Research & Development (DPRD) is part of the Pharmaceutical Development organization and plays a crucial role in delivering medicines to our patients during the development phase of a new product. Within this organization, the Pharmaceutical Supply & Engineering Sciences team (PSES) is responsible for the upscaling and fine tuning of formulation and processes which result in the successful clinical manufacturing of new Drug Product (DP). Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year.

For our DP Pilot plant in Beerse, Antwerp, Belgium we are looking for an Engineer, cleaning and sterilization validation in the MST team. You will be accountable for the cleaning validation, sterilization validation (and process validation when applicable) for the internal Drug Product Pilot Plant (DP-Pilot Plant).

As a cleaning and sterilization validation engineer you will be a core member of the Pharmaceutical Supply and Engineering Sciences organization.

You are responsible for successfully supporting the base business validations and delivering on project work covering validation aspects together with a team of validation engineers in the Drug Product (DP)-Pilot Plant (PP)

Working within an international setting and in cross functional teams, the cleaning and sterilization validation engineer is responsible for and supports:

• Accountability for base business verification/validation activities according to validation master plan
• Provide and execute on validation requirements in portfolio and technical projects
• Process owner for certain validation processes and spokesperson in regulatory and/or customer audits
• Implementation of optimizations and defining new/updated validation strategies
• Establish relationships with a network of internal and external experts on validation (CoP, ...)

All the mentioned assignments should be performed in accordance with:

• Current regulatory requirements
• J&J guidelines

Technologies span over equipment for manufacturing oral solids, liquids and parenteral applications, together with supporting equipment for cleaning (parts washer, CIP) and for sterilization (autoclave, SIP).

As a key player of our PSES team, you will help shape the future of drug product formulation and process development. Your responsibilities will include:

• Transformative Process Improvement and Optimization: Drive the evolution of existing workflows by addressing challenges head-on and uncovering opportunities to improve way of working
• Innovation-Focused Expertise - Development and Collaboration for Success:
  • Cultivate expertise through cross-functional collaboration with QA and subject matter experts, ensuring alignment with latest industry standards.
  • Take ownership of the validation approach for the clinical manufacturing activities in the internal pilot plant, acting as a key collaborator and partner for the clinical operational department, contributing to advancements in pharmaceutical manufacturing and assuring right-first-time manufacturing of clinical drug product material.

• MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering, or other discipline within pharmaceutical/biotechnology sciences with preferably a few years of experience in GMP regulated pharmaceutical development/engineering area.
• Experience working in regulated environments (e.g., FDA standards, general GMP guidelines, Annex 1) is important. Awareness of relevant guideline and regulation regarding validation and sterile manufacturing through literature, workshops, and training is beneficial.
• Good organizational and coordination skills, with knowledge of risk management. Able to search literature and utilize other resources effectively to apply and advance knowledge practically.
• Good collaboration and influencing skills to establish working relationships with internal teams (focus on internal cross-functional partners and pilot-plant teams).
• Technical expertise is valued, alongside developing project management skills.
• Understanding of qualification, validation, and change management systems in the pharmaceutical industry is an advantage.
• Ability to work independently under challenging timelines while maintaining a focus on quality is important.
• Fluency in English, both written and spoken, is required. Proficiency in Dutch is a helpful additional skill.

• Exciting Opportunities: Join an international and dynamic environment that promotes continuous learning and personal growth.
• Prime Location: Work at a site that encompasses all aspects of drug discovery and development, just a stone's throw from the vibrant city of Antwerp.
• Competitive Benefits: Enjoy a competitive salary, on-site sports facilities, health programs, and family benefits that support your well-being.
• Inclusive Culture: Be part of a diverse team where your opinions are valued, and a healthy work-life balance is a priority.

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