Operations Associate Formulation and Material Preparation (m/w/d)

Eli Lilly Eli Lilly · Pharma · Alzey, Germany

This role is for an Operations Associate in Formulation and Material Preparation at a new high-tech manufacturing facility for injectable medicines. The role involves supporting commissioning, qualification, and validation during the project phase, and day-to-day performance management after site start-up. Key responsibilities include leading investigations, presenting to regulatory authorities, defining and procuring supplies, developing training materials, managing flows, and driving continuous improvement. The ideal candidate has a bachelor's degree, at least one year of pharmaceutical industry experience, strong organizational and project management skills, and excellent German and English.

What you'd actually do

  1. You will support the area leadership team and ensure high standards of safety, quality, and productivity to guarantee reliable patient supply.
  2. You will lead and facilitate deviation investigations and corrective actions as the lead investigator with a cross-functional team.
  3. You will present operational investigations and procedures to regulatory authorities and act as a subject matter expert (SME) during inspections, tours, and discussions.
  4. You will lead site operational readiness activities and programs.
  5. You will define and procure consumables and supplies.

Skills

Required

  • bachelor’s degree in a technical or pharmaceutical-related field
  • at least one year of experience in the pharmaceutical industry, preferably in compounding and material preparation
  • understanding of the basic requirements of regulatory authorities such as the FDA, EMA, or comparable organizations
  • work independently and proactively
  • strong organizational and project management skills
  • excellent interpersonal skills
  • technical writing skills and experience in creating standard operating procedures, work instructions, and training documentation
  • Excellent German and English skills
  • very good MS Office proficiency

What the JD emphasized

  • at least one year of experience in the pharmaceutical industry
  • understanding of the basic requirements of regulatory authorities such as the FDA, EMA, or comparable organizations
  • Excellent German and English skills