Validation Engineer/Scientist
Eli Lilly and Company
8 days ago
On-site
Pleasant Prairie, WI
Operations
Position Overview
The Validation Engineer/Scientist – Technical Services / Manufacturing Science (TS/MS) role develops and supports validation of production equipment and systems and provides technical leadership for temperature mapping, cleaning and sterilization validation strategies. Supports start-up and compliant manufacturing of Lilly Kenosha County products, including sterilization, cleaning, and filter validation. Mentors within the TSMS team and engages in upstream/external validation activities.
Responsibilities
- Understand scientific principles for manufacturing parenteral drug products (chemistry, equipment, aseptic processes, container closure systems).
- Support start-up activities for temperature mapping, cleaning and sterilization programs.
- Develop/execute cleaning and sterilization validation strategies for equipment/systems (e.g., tanks, washers, autoclaves, filling isolators).
- Support periodic requalification.
- Author/support validation protocols and reports.
- Provide technical guidance for cleaning and sterilization processes.
- Lead/support root cause investigations related to cleaning/sterilization.
- Analyze manufacturing data using statistics to identify trends and continuous improvement opportunities.
- Coordinate cross-functional teams to improve productivity, quality, and cleaning/sterilization.
- Support internal/external audits (including regulatory inspections) as needed.
- Prepare/review/approve technical documents (change controls, regulatory submissions, deviation investigations, protocols/summary reports, etc.).
- Support/lead TS/MS projects for start-up, process control, yield, quality, and productivity; implement improvements.
- (Senior/Principal) Serve as external cleaning/sterilization interface.
- Ensure safe work environment via safety rule compliance and safety participation.
Basic Qualifications
- Bachelor’s degree in microbiology, biology, biochemistry, biochemical engineering, chemical engineering, or related.
- 2+ years’ experience supporting cGMP manufacturing (preferred: validation/engineering/technical services/operations/QA).
- Experience supporting cGMP manufacturing.
Additional Skills/Preferences
- Experience executing equipment qualification, cleaning validation, sterilization validation.
- Data trending/analysis; ability to analyze complex data and solve problems.
- Strong cross-functional interpersonal/teamwork and organizational skills.
Additional Information
- Available off shift for operational issues.
- Ability to travel (~10%).
The Validation Engineer/Scientist – Technical Services / Manufacturing Science (TS/MS) role develops and supports validation of production equipment and systems and provides technical leadership for temperature mapping, cleaning and sterilization validation strategies. Supports start-up and compliant manufacturing of Lilly Kenosha County products, including sterilization, cleaning, and filter validation. Mentors within the TSMS team and engages in upstream/external validation activities.
Responsibilities
- Understand scientific principles for manufacturing parenteral drug products (chemistry, equipment, aseptic processes, container closure systems).
- Support start-up activities for temperature mapping, cleaning and sterilization programs.
- Develop/execute cleaning and sterilization validation strategies for equipment/systems (e.g., tanks, washers, autoclaves, filling isolators).
- Support periodic requalification.
- Author/support validation protocols and reports.
- Provide technical guidance for cleaning and sterilization processes.
- Lead/support root cause investigations related to cleaning/sterilization.
- Analyze manufacturing data using statistics to identify trends and continuous improvement opportunities.
- Coordinate cross-functional teams to improve productivity, quality, and cleaning/sterilization.
- Support internal/external audits (including regulatory inspections) as needed.
- Prepare/review/approve technical documents (change controls, regulatory submissions, deviation investigations, protocols/summary reports, etc.).
- Support/lead TS/MS projects for start-up, process control, yield, quality, and productivity; implement improvements.
- (Senior/Principal) Serve as external cleaning/sterilization interface.
- Ensure safe work environment via safety rule compliance and safety participation.
Basic Qualifications
- Bachelor’s degree in microbiology, biology, biochemistry, biochemical engineering, chemical engineering, or related.
- 2+ years’ experience supporting cGMP manufacturing (preferred: validation/engineering/technical services/operations/QA).
- Experience supporting cGMP manufacturing.
Additional Skills/Preferences
- Experience executing equipment qualification, cleaning validation, sterilization validation.
- Data trending/analysis; ability to analyze complex data and solve problems.
- Strong cross-functional interpersonal/teamwork and organizational skills.
Additional Information
- Available off shift for operational issues.
- Ability to travel (~10%).