Yacht Freelance
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