Senior/principal Scientist Validation

Eli Lilly Eli Lilly · Pharma · Alzey, Germany

This role is for a Senior/Principal Scientist Validation at Eli Lilly's new production facility in Alzey, Germany. The primary focus is on instructing and supporting the validation of production equipment and systems, including sterilization, cleaning, filter, shipping, and process validation. The role involves preparing and reviewing technical documents, participating in process functional teams, and ensuring compliance with GMP and quality objectives. It is an onsite position requiring a degree in engineering or pharmacy with at least 5 years of industry experience and knowledge of GMP operations.

What you'd actually do

  1. Instruct and support the validation of production equipment and systems.
  2. Prepare, review relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures.
  3. Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.
  4. Initiate related validation protocols and reports, and coordinate validation related activities Complete required and assigned trainings on-time.

Skills

Required

  • Engineer, pharmacist, or equivalent with professional experience (at least 5 years) in the industry
  • Knowledge of GMP Operation skills
  • Good knowledge of document and project management
  • German and basic English knowledge

Nice to have

  • Additional German is preferred
  • Parenteral manufacturing
  • Strong analytical and synthesis skills
  • Excellent interpersonal and communication skills
  • Ability to work independently and in a team
  • Ability to coordinate teams without direct hierarchical power

What the JD emphasized

  • GMP Operation skills