Elanco
Quality Operations Specialist (Aseptic)
Winslow, ME · Mid
Sponsorship not specifiedDetected 26 days ago
TypeScriptProcess ImprovementGMPFDA RegulatoryCollaborationTime ManagementProcess SimulationLean Manufacturing
About the role
- Acting as a subject matter expert, this role involves cross-functional collaboration with production, QC, and TS/MS teams.
- The primary goal is to improve site Sterility Assurance programs, including aseptic training/qualification, Aseptic Process Simulation (APS), and Environmental Monitoring (EM).
- Provide technical and SME input for various programs including Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, while maintaining lifecycle documentation.
Responsibilities
- Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.
- Assist in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training.
- Provide oversight during the execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support corrective actions including RCI and CAPA.
- Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to all relevant policies and regulations.
- Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills.
Requirements
- Minimum 5 years experience working in a regulated USDA and/or US/EU GMP manufacturing environment
- What You Need to Succeed (minimum qualifications):
Nice to have
- Experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning.
- Experience with sterile manufacturing risk assessments and remediations implementation.
- Lean manufacturing and six sigma experience.
- Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential.
- What Will Give You the Competitive Edge (preferred qualifications):
Compensation
- Annual bonus offering
Benefits
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- Annual bonus offering
- As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
Company info
- At Elanco we are dedicated to building a diverse and inclusive work environment.
This listing is sourced directly from Elanco's careers page and normalized into a canonical job model.