MSAT Process Specialist / Expert – Formulation and Filling (m/f/d)

In this role you will be part of the TS/MS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TS/MS team is the technical owner of the process, from tech transfer and validation through commercial lifecycle management. Decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site runs for the next decades, with direct visibility to site leadership and Lilly's global technical network. Role is Monday through Friday site-based (Alzey) with the ability to travel to Indianapolis and other global Lilly sites as required. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).

Responsibilities

Maintain a safe work environment and support all HSE corporate and site goals; Act as TS/MS representative for the Formulation & Filling processes, addressing complex process issues and escalating as appropriate; Act as link between operations, product team and local stakeholders for process related topics; Ensure the preparation, formulation and filling process follow industry and authority expectations and comply with applicable regulations; Provide technical guidance for formulation and aseptic filling processes to the whole site and serve as a source of knowledge to operational staff; Support validation and lifecycle management of filling processes, equipment, and control strategies; Own complex process deviations and drive change controls; Collaborate cross-functionally to drive continuous improvement and present responsible area during inspections and audits; Ensure processes, procedures, and batch documentation are accurate, executable, and compliant with GMP and regulatory expectations

Requirements

Degree as engineer, pharmacist, or equivalent qualifying certification/training; At least 5 years of professional experience in the pharmaceutical industry; Knowledge of GMP and operational skills; Good knowledge of document and project management; German language proficiency and basic English knowledge

Nice to have

Experience in 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; Able to communicate in German

Benefits

Company bonus (depending on company and individual performance); Pension plan eligibility; Vacation benefits; Healthcare benefits eligibility; Flexible benefits (if applicable); Life insurance and death benefits; Time off and leave of absence benefits; Well-being benefits (employee assistance program, fitness benefits, employee clubs and activities)