Freelance (Sr) Validation Engineer / Quality Compliance (Life Sciences) (ZZP)

Job Description:

Yacht Life Sciences has a vacancy for a (Sr) Validation Engineer /Quality Compliance to work within the MSAT-SPV Team of Johnson & Johnson Innovative Medicine in Leiden (the Netherlands).The Engineer is a member of the MSAT-SPV Team with the dedicated focus on:1. Validation of Supporting Processes (e.g. Cleaning, Mixing, Sterilization).2. Process improvements and standardization.3. New technology deployment.

Essential Job Duties and Responsibilities:

• Lead the execution of validation activities such as cleaning validation, sterilization validation, mixing validation, and temperature mapping.

• Write and review validation plans, protocols and reports.

• Communicate with stakeholders to coordinate timing of execution, provide status updates, and escalate issues.

• Act as Project Core Team Member for medium-sized projects and as such:

• Define validation strategy.

• Represent MSAT in multidisciplinary team and align with extended team members.

• Plan and deliver team/project Goals and Objectives. Manage timelines and communicate project status.

• Provide direct input to resource planning.

• Act as SME for one or more validation categories. Leverage global MSAT network to identify and implement industry best practices.

• Participate in preparation and represent MSAT in audits/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.)

Job requirements:

• BSc/HBO (or equivalent) or Master’s degree in bioscience, biotechnology, biochemistry, pharmacy biomedicine, process technology, Engineering or Technical subject

• > 4 years of relevant experience in the (bio)pharmaceutical industry or related post graduate academic experience/education is required. 

• Knowledge of and experience in a scientific or technical core area and building knowledge and experience in other technical and business disciplines

• Proven experience with GMP and Quality Compliance