Joining the Manufacturing Science and Technology (MSAT) team, you will ensure the successful delivery of validation activities within a GMP environment. This role focuses heavily on Cleaning Validation, while providing secondary support for thermal validation, process improvements, and New Product Introductions (NPI).
Key Responsibilities
- Validation Strategy: Plan, document, and execute cleaning validation studies, including protocol development (SOPs, WIs) and technical report generation.
- Compliance & Quality: Conduct all activities in alignment with US/EU regulations (FDA/EMEA) and EHS&S requirements; manage change controls, deviations, and investigations.
- Project Leadership: Lead or provide technical guidance for process improvement projects and site-level technical platform teams.
- Cross-Functional Collaboration: Coordinate with Manufacturing, contractors, and vendors to ensure validation schedules align with production goals.
Qualifications & Experience
- Education: Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy, or a related scientific field.
- Industry Experience: Minimum 2 years in Large Molecule manufacturing or a similar high-complexity environment.
- Technical Expertise: Proven experience in Cleaning Validation studies and strategies is highly desirable.
- Regulatory Knowledge: Strong working knowledge of FDA, HPRA, and EMEA regulations.
- Soft Skills: Excellent interpersonal communication, analytical problem-solving, and the ability to work independently under general direction.
