Sterility Assurance Lead – Aseptic & Contamination Control

Elanco Tiergesundheit AG; United States; Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation packages

Annual bonus

Flexible work arrangements

8-week parental leave

401K matching

Job summary

Elanco is seeking a Quality Assurance Advisor, Sterility Assurance, to oversee and contribute to Sterility Assurance/Contamination Control within the Biotech network. You will collaborate cross-functionally to improve aseptic programs, training, APS, EM, and overall compliance with GMP and regulatory expectations.

The role involves authoring EFPs, supporting validations, and providing SME input across processes, equipment, and facilities.

Qualifications

• B.S. in engineering, microbiology/biology, or equivalent discipline.
• 10+ years' experience with parenteral, biological, or vaccine manufacturing operations.
• Familiarity with FDA, EU GMP, USDA, and CFIA regulations.

Responsibilities

• Provide technical and SME input for Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, maintaining lifecycle documentation.
• Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to policies and regulations.
• Author and develop Elanco Functional Procedures for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.
• Assist in troubleshooting, perform gap/risk assessments, support regulatory inspections, and conduct necessary training.
• Provide oversight during execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support CAPA.

Skills

Sterility Assurance

Aseptic Processing

Environmental Monitoring

Process Validation

Regulatory Compliance

QA Collaboration

Education

B.S. in engineering or microbiology

Job description

Elanco is seeking a Quality Assurance Advisor, Sterility Assurance, to oversee and contribute to Sterility Assurance/Contamination Control within the Biotech network. You will collaborate cross-functionally to improve aseptic programs, training, APS, EM, and overall compliance with GMP and regulatory expectations.

The role involves authoring EFPs, supporting validations, and providing SME input across processes, equipment, and facilities.