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API Production Operator
Eli Lilly and Company. Support project delivery and startup activities for the Lilly Medicine Foundry .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in API manufacturing and cGMP compliance, with strong organizational skills to manage production plans and operational challenges effectively. Capable of supporting facility startup activities and ensuring adherence to safety and quality standards.
Highest-signal resume keywords
API Manufacturing ExperienceCGMP ComplianceLean Manufacturing PrinciplesTroubleshooting SkillsSafety Audits Participation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GMP OperationsBatch Records ManagementEquipment MonitoringPerformance Data CollectionTechnical Nomenclature Understanding
Soft Skills
Strong Organizational SkillsEffective CommunicationAbility to Prioritize Requests
Tools & Technologies
Personal Protective Equipment (PPE)
Industry Keywords
FDA GuidelinesChemical ProcessingPSM-Regulated ChemicalsFacility StartupHazardous Chemicals
About the role
Key responsibilities & impact- Support project delivery and startup activities for the Lilly Medicine Foundry
- Help build the organization, systems, business processes, and site culture required for GMP operations
- Support startup activities to bring manufacturing equipment into service
- Become an expert in an assigned Small Molecule, Hybrid, or Biologics area and educate the team on facility operation
- Travel domestically and internationally to collaborate, train, and learn from sites producing APIs
- Upon project completion, directly oversee API molecule production
- Support daily activities to meet production plans
- Follow safety, quality, environmental, GMP, and compliance requirements
- Operate processes and equipment according to batch records, manuals, design parameters, SOPs, and work instructions
- Perform daily monitoring, testing, and cleaning of equipment and systems
- Recognize operational hazards and respond appropriately
- Monitor and collect equipment-use and performance data to anticipate reliability problems
- Contact appropriate support for spills, deviations, incidents, and other manufacturing events
- Communicate operational status and issues during shift handovers
- Participate in daily shift huddles and meetings
- Participate in safety audits, procedure coordination, housekeeping, and continuous improvement projects
- Follow cGMP practices, safe work habits, dress code, hygiene standards, and housekeeping requirements
Requirements
What you’ll need- HS Diploma/GED
- 3+ years of API manufacturing experience; GMP and/or chemical processing preferred
- Legally authorized to be employed in the United States
- No anticipated employment visa sponsorship for this position
- Previous experience in facility or area start-up environments preferred
- Previous experience in pharmaceutical or chemical manufacturing involving PSM-regulated or hazardous chemicals preferred
- Solid understanding of FDA guidelines and cGMP requirements
- Strong organizational skills with ability to handle and prioritize multiple requests
- Knowledge of lean manufacturing principles
- Ability to troubleshoot and triage challenges effectively
- Ability to understand technical nomenclature and language and work with mathematical formulas
- Ability to work a 12-hour rotating shift (3-2-2-3, rotating every 8 weeks between day and night shift)
- May be required to work outside normal hours, including nights, weekends, and holidays
- Ability to use required company-supplied personal protective equipment (PPE)
Benefits
Comp & perks- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities