Job Description
Yacht Life Sciences has a vacancy for a (Sr) Equipment 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.)