Leiden site Technical Operations (TO) is part of the global Technical Operations organization. TO is responsible for validation and standardization of processes and equipment within the Janssen Biologics site and manages Life Cycle Management (LCM) projects and improvement projects. We accomplish this through our broad technical competency, global reach and local execution power. A job within the TO team is very dynamic and diverse. For the Sr Engineer position, we are looking for someone who likes challenges, is collaborative and is keen on working within local as well as global project teams. We look for a candidate with strong knowledge and experience in bioprocessing and compliance. A self-starter, who would like to take initiative and can define new strategies for implementation of new equipment and products. Specific tasks:
- The Sr Engineer is primary responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines. The studies must meet the quality requirements. This function encompasses cleaning, mixing and sterilization validation of production equipment.
- You are responsible to maintain and continue to improve the validation process. This includes defining and developing new validation strategies for the implementation of new equipment and NPIs.
- You will train and coach engineers in GMP compliance and perform the internal review of protocols and reports.
- You are responsible for preparation of protocols and execution of studies. Lead and support the coordination of studies.
- Participate in multidisciplinary projects as independent core team member to represent TO.
- Assessment of change controls and preparing of validation assessments.
- Lead and Support in deviation investigations.
- Establish and maintain contact with colleagues of other (large molecule) sites
- Minimal Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering)
- Minimal 5 year relevant experience in the (bio-) pharmaceutical industry;
- Precise, accurate, structured, flexible and customer focused;
- Proven experience with GMP and compliance
- Expertise in process excellence and/or project management is a plus;
- Good communicative skills in English language (writing and verbal), Dutch is a plus
Janssen Biologics (7266)Job Function