Associate Director - Validation TS/MS

Associate Director - Validation TS/MS

Eli Lilly Benelux

Alzey, Germany

Key Objectives/Deliverables:

• Responsible for maintaining a safe work environment, working safely and accountable to support all HSE corporate and site goals;
• Building and leading a team in alignment with the Lilly values to support initial and revalidation of the process;
• Fully accountable for planning execution of sterilization validation, cleaning validation, filter validation, shipping validation, temperature mapping and other validations;
• Build robust systems for revalidation incl. Coordination with stakeholders as engineering, operations and quality;
• Ensure correct governance to steer validation activities. Manage stakeholders incl. leadership team and align with operational planning;
• Coach team to increase maturity and support technical development;
• Own validation concepts and ensure alignment within the network;
• Manage investigations of complex validation deviations related to cleaning, sterilization, filtration, and temperature mapping and give guidance to the extended team to manage product impact assessments;
• Prepare and provide technical review of completed/executed validation packages by compiling and analysing validation data;
• Manage external contracts/resources and project management resources, as needed;
• Present validation related topics during health authority inspections;
• Maintain an up-to-date knowledge of validation requirements, industry best-practices, and benchmark within the Lilly network.

Expected Qualifications:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline;
• Understanding of GMPs and manufacturing processes;
• Experience in building and leading a team;
• Extensive knowledge with equipment qualification and/or cleaning, decontamination, sterilization process validation;
• Strong knowledge of risk management and understanding / ability to use risk assessment tools as part of a validation strategy;
• Ability to analyse complex data and solve problems;
• Strong technical writing and presentation skills;
• Fluent in English;
• English Resume only please.

Additional Preferences:

• Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.);
• Able to communicate in German.