Validation Scientist Cleaning & Sterilization
Eli Lilly and Company
5 hours ago
On-site
Durham, NC
Operations
Job Summary
- Validation Scientist (Cleaning & Sterilization). Develop and support validation of production equipment/systems and provide technical leadership for cleaning, sterilization, and temperature mapping validation strategies.
Job Responsibilities
- Understand scientific principles for manufacturing parenteral drug products, device assembly/packaging (chemistry, equipment, aseptic processes, container closure systems).
- Lead design, execution, and documentation of validation studies for manufacturing equipment in compliance with cGMP, FDA, EMA, and other regulatory guidelines.
- Support start-up activities for temperature mapping, cleaning, and sterilization programs.
- Assist with development/execution of cleaning and sterilization strategies validating equipment/systems (e.g., tanks, parts washers, autoclaves, filling isolators).
- Support periodic requalification of production equipment/systems.
- Author/support validation protocols and reports; provide technical guidance to the Process Team.
- Lead/support root cause investigations (cleaning, sterilization, temperature mapping).
- Analyze manufacturing data statistically to identify trends, disruptions, and improvement opportunities.
- Coordinate cross-functional teams on projects improving productivity/quality/continuous improvement.
- Support audits/inspections for equipment cleaning and sterilization programs as needed.
- Prepare/review/approve technical documentation (change controls, regulatory submissions, deviation investigations, protocols and summary reports, processing records, procedures, VMPs/APRs/QPPAs, etc.).
- Support/lead TS/MS technical projects for start-up success and process control/yield/product quality/productivity.
- Perform risk assessments and implement control strategies.
- Develop/maintain Validation strategy documents; serve as SME for cleaning/sterilization/temperature mapping outside the RTP site.
- Execute/manage temperature mapping studies; work with cross-functional teams to deliver TS/MS and business/quality objectives.
- Collaborate across the Parenteral Network and supply chain teams.
- Ensure safe working environment and improve safety culture through safety rule compliance and participation.
Job Qualifications
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
- Experience supporting cGMP manufacturing (operations, validation, engineering, technical services/MSAT, quality assurance, etc.).
- Familiarity with sterilization methodologies (steam, dry heat, EtO, gamma irradiation).
- Excellent written/verbal communication; present complex technical information clearly.
- Strong problem-solving/analytical skills; attention to detail.
- Ability to work independently and collaboratively in a fast-paced team environment.
Preferred
- 3–5+ years in pharmaceutical/biotech/medical device industry with direct cleaning validation and/or sterilization validation experience.
- In-depth cGMP knowledge (21 CFR Parts 210, 211), FDA guidance, EU GMP Annex 15, and other international validation standards.
- Proven experience developing/executing validation protocols and reports.
Benefits (if provided)
- Eligibility for company bonus (for full-time equivalent employees).
- Comprehensive benefits program: 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance/death benefits; time off/leave of absence; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application/Accommodation Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Validation Scientist (Cleaning & Sterilization). Develop and support validation of production equipment/systems and provide technical leadership for cleaning, sterilization, and temperature mapping validation strategies.
Job Responsibilities
- Understand scientific principles for manufacturing parenteral drug products, device assembly/packaging (chemistry, equipment, aseptic processes, container closure systems).
- Lead design, execution, and documentation of validation studies for manufacturing equipment in compliance with cGMP, FDA, EMA, and other regulatory guidelines.
- Support start-up activities for temperature mapping, cleaning, and sterilization programs.
- Assist with development/execution of cleaning and sterilization strategies validating equipment/systems (e.g., tanks, parts washers, autoclaves, filling isolators).
- Support periodic requalification of production equipment/systems.
- Author/support validation protocols and reports; provide technical guidance to the Process Team.
- Lead/support root cause investigations (cleaning, sterilization, temperature mapping).
- Analyze manufacturing data statistically to identify trends, disruptions, and improvement opportunities.
- Coordinate cross-functional teams on projects improving productivity/quality/continuous improvement.
- Support audits/inspections for equipment cleaning and sterilization programs as needed.
- Prepare/review/approve technical documentation (change controls, regulatory submissions, deviation investigations, protocols and summary reports, processing records, procedures, VMPs/APRs/QPPAs, etc.).
- Support/lead TS/MS technical projects for start-up success and process control/yield/product quality/productivity.
- Perform risk assessments and implement control strategies.
- Develop/maintain Validation strategy documents; serve as SME for cleaning/sterilization/temperature mapping outside the RTP site.
- Execute/manage temperature mapping studies; work with cross-functional teams to deliver TS/MS and business/quality objectives.
- Collaborate across the Parenteral Network and supply chain teams.
- Ensure safe working environment and improve safety culture through safety rule compliance and participation.
Job Qualifications
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
- Experience supporting cGMP manufacturing (operations, validation, engineering, technical services/MSAT, quality assurance, etc.).
- Familiarity with sterilization methodologies (steam, dry heat, EtO, gamma irradiation).
- Excellent written/verbal communication; present complex technical information clearly.
- Strong problem-solving/analytical skills; attention to detail.
- Ability to work independently and collaboratively in a fast-paced team environment.
Preferred
- 3–5+ years in pharmaceutical/biotech/medical device industry with direct cleaning validation and/or sterilization validation experience.
- In-depth cGMP knowledge (21 CFR Parts 210, 211), FDA guidance, EU GMP Annex 15, and other international validation standards.
- Proven experience developing/executing validation protocols and reports.
Benefits (if provided)
- Eligibility for company bonus (for full-time equivalent employees).
- Comprehensive benefits program: 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance/death benefits; time off/leave of absence; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application/Accommodation Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation