Responsibilities
The Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities at Eli Lilly’s newly acquired Kenosha County site. This role is required to bring the area into service which may include formulation, aseptic isolator barrier filling, and equipment preparation. They will become the experts within their assigned area and educate their team in the proper operation of the facility. This position may require travel (2-4 week trips and/or 3-12 month short term assignments) domestically with the opportunity for travel internationally to collaborate, train with, and learn from sites who currently produce our medicines.
After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first/quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team’s capabilities.
As a site leader and expert at our growing site, you’ll have significant opportunities for growth into future leadership and technical roles.
Key Objectives/Deliverables:
Integrity
- Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
- Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
- Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
- Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the production floor.
- Responsible for administering technical training and ensuring all operators are trained to perform tasks.
- Operate the equipment and perform activities as required to meet production schedule.
- Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
- Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Respect for People
- Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
- Key liaison between operations and support functions.
Basic Qualifications
- We have several levels open for Operator which are based on the experience and education you bring.
- Minimum education: High School Diploma or GED
- Ability to effectively communicate (electronically, written and verbal)
- Flexibility – the ability to troubleshoot and triage challenges
- Computer proficiency (desktop software, MS office).
Time Commitments and Work Authorization
- Must Pass a “fitness for duty” physical exam
- Shift flexibility
- Ability to work overtime as required.
- Ability to wear safety equipment (glasses, shoes, gloves, etc)
- Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
- Ability to participate in professional development opportunities
- Depending on the candidate’s experience, the position may require a short-term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/ Preferences
Experience with, completion of, or understanding of:
- Leadership and the ability to train/educate team members.
- STEM degree or certifications
- Aseptic filling, single use assemblies, isolator technology.
- Automated, semi-automated, and/or manual inspection.
- Knowledge of current Good Manufacturing Practices (CGMPs)
- Experience in operations or manufacturing environments.
- Pharmaceutical, medical device or food processing industries
- Manufacturing Execution Systems and electronic batch release.
- Continuous improvement (Lean, Six Sigma methodologies)
- Highly automated equipment (inspection, packaging, filling, assembly, etc)
- SAP, Electronic Batch Records
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
