MSAT Process and Validation Expert
This role requires a guide on process and cleaning validation of drug substance for upstream and downstream areas. The ideal candidate will have 8+ years of experience in GMP manufacturing, including knowledge of process equipment.
Responsibilities:
1. Establish and supervise validation KPIs to ensure efficiency and effectiveness in the production process.
2. Plan, perform, coordinate, and report on process and cleaning validation activities, including cleaning validation, PPQ, CPV, E&L, and encouraging studies with internal and external partners.
3. Support global validation strategy definition and implementation by ensuring aligned approaches and managing knowledge exchange across teams.
4. Collaborate with various departments such as Manufacturing, Engineering, Regulatory, and Quality to ensure Health Authority Inspection readiness.
5. Represent Process and Cleaning Validation and Manufacturing Sciences in multi-functional teams, including customer meetings to deliver exceptional customer service and experience.
Requirements:
1. Degree (Bachelor or Master) in Life Sciences (Biology, Chemistry, etc.), Engineering Degree, or equivalent.
2. 8+ years of experience in Drug Substance GMP manufacturing with expertise in upstream and downstream process areas and related equipment.
3. Excellent analytical and writing skills, with experience in creating technical reports and presentations.
4. Strong multicultural and cross-disciplinary project team experience.
5. Proficiency in planning, problem-solving, critical thinking, writing, communication, and presentation skills.
6. Language proficiency in English is required, with German knowledge being an asset.
What We Offer:
You will work in a dynamic and international environment with opportunities for growth and development. Our company values integrity, intensity, involvement, and innovation, and offers a well-founded induction and task-specific training, competitive remuneration, annual incentive plan bonus, healthcare, and other employee benefits.