Johnson & Johnson Loopbaan
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Engineer / Process Excellence specialist
Requisition ID: 1700203670W
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-skilled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Operations Team in Drug Substance Operations (DSO) we are looking for an enthusiastic and talented:
Engineer/ Process Excellence specialist
The department Drug Substance Operations (DSO) is an international team of about 40 people working on manufacturing of clinical batches (phase I to III) to support the development of new vaccines. The department consists currently of three teams all with their own responsibilities: Preparations, Fermentation and Downstream processing. Production is performed under strict cGMP regulations. Execution of the manufacturing process is done in close collaboration with the development department, as well as engineering & maintenance, QC, QA and warehouse. Furthermore, in the future close collaboration with the launch facility is expected.
Together the teams are capable to produce 30 batches on a yearly basis and the department is exploring options to further increase this capacity. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, master batch documentation, training and inspection readiness.
As Engineer and Process Excellence (PE) specialist you will be the first point of contact with Engineering, Validation and Maintenance (EVM) to introduce new equipment and maintain the existing equipment. Together with development groups (Upstream processing/ downstream processing) processes compliant with current cGMP regulations are introduced in the pilot facility including documentation and training. Leading role in improved equipment management on departmental level in line with cGMP and Environment Health Safety and Sustainability (EHSS) regulations. Supporting in trouble shooting, investigation in non-conformances (process and equipment related). Shape and maintain a PE/lean culture by continuous improvements, problem solving (GEMBA, KAIZEN facilitator, A3).
- Leading role in the availability of cGMP and EHSS compliant equipment and processes in the department
- SME during inspections
- Supporting / leading in EHSS incidents
- Systems and processes are compliant to global, EHSS and compliance standards
- Leading / supporting process excellence activities to continuously improve the work and personal skills
- Initiating and handling of equipment related compliance records (CC, nonconformance’s and CAPA records)
- Working precisely and detecting opportunities for improvement with proper follow up.
- First departmental contact for questions about equipment
- HBO with 6-8 years’ experience in pharmaceutical industry / biotechnology
- Proven experience with Lean / Process Excellence is required
- Minimal certified Lean / PE green belt
- Quality Assurance understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance and engineering (e.g. GMP, NEN 3140, VCA, CE)
- Project management skills
- Proven experience with handling change controls, deviations, etc.
- High degree of accuracy, initiative, and independence.
- Flexible, can deal with changing priorities and stress-resistant.
- Enthusiastic Team player, good in building relations with variety of people and departments
- “Can do” attitude, critical and proactive.
- Good communication in Dutch and English, both verbally and in writing.
- Analytical and organized
Janssen Vaccines & Prevention BV (8852)