Validation Engineer - Sterilization & Cleaning Expert

Eli Lilly and Company; Wisconsin; On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Performance bonus

401(k) plan

Health benefits

Job summary

Eli Lilly and Company in Wisconsin seeks a Validation Engineer/Scientist to develop and support validation activities for production equipment and systems, including temperature mapping, cleaning and sterilization validation strategies.

The role includes mentoring the TS/MS team, leading validation protocols, and supporting internal and external audits to ensure compliant startup and ongoing manufacturing performance. Strong collaboration across parenteral networks is expected.

Qualifications

• Bachelor's degree in microbiology, biology, biochemistry, biochemical or chemical engineering, or related science.
• 2+ years’ experience supporting cGMP manufacturing.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Understand scientific principles for parenteral manufacturing and equipment interactions.
• Provide technical support for temperature mapping, cleaning and sterilization programs.
• Develop and execute cleaning/sterilization validation strategies for production equipment and systems.
• Support requalification activities and prepare validation documentation.
• Lead investigations related to cleaning, sterilization, and process deviations.
• Collaborate with cross-functional teams to implement TS/MS improvements during audits.

Skills

Bachelor's degree

2+ years cGMP experience

US work authorization

Validation experience

Job description

Eli Lilly and Company in Wisconsin seeks a Validation Engineer/Scientist to develop and support validation activities for production equipment and systems, including temperature mapping, cleaning and sterilization validation strategies.

The role includes mentoring the TS/MS team, leading validation protocols, and supporting internal and external audits to ensure compliant startup and ongoing manufacturing performance. Strong collaboration across parenteral networks is expected.