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Manufacturing Associate - Advanced Manufacturing

Eli Lilly8 months ago
Lebanon, Indiana, United States
On-site
Full-time
Junior Level (1-3 years)
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Job Description

Key Responsibilities

  • Work cross functionally with TSMS and Engineering to develop procedures, MES records, and establish operational controls.
  • Work in a cleanroom environment to produce advanced therapies in a safe and quality manner.
  • Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of advanced therapies.
  • Participate in equipment commissioning and qualification testing and process validation activities in collaboration with other departments.
  • Safely work with BSL-2 materials, following site biologics safety program.
  • Conduct and appropriately document production of advanced therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.
  • Utilize and monitor manufacturing equipment to ensure performance and safety standards are met.
  • Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
  • Provide verbal and written reports to supervisors and other teams in a clear and concise manner.
  • Maintain accurate and complete electronic records and logbooks as per cGLP and/or cGMP, as appropriate.
  • Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
  • Comply with cleanroom gowning requirements for completing specific work in drug substance and drug product.
  • Work well in a fast-paced team environment.

Required Qualifications

  • High School diploma + 5 years of operations experience OR Bachelor’s degree in STEM field and 1+ year of operations experience.

Preferred Qualifications

  • Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
  • Technical problem-solving skills.
  • Good communications skills (both oral and written).
  • Willingness to learn and understand Good Manufacturing Practices and strict adherence to GMP regulations.
  • Good organization skills.
  • Ability to work with and learn new digital systems.
  • Attention to detail.

Benefits & Perks

  • Eligibility to participate in a company-sponsored 401(k) plan and pension.
  • Vacation benefits.
  • Medical, dental, vision and prescription drug benefits available.
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
  • Life insurance and death benefits.
  • Certain time off and leave of absence benefits.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Required Skills

Equipment commissioning
Safety compliance
Electronic records management
Cleanroom operations
Process validation
Cross-functional collaboration
cGMP and cGLP adherence
Verbal and written reporting
Quality control coordination
Digital manufacturing
Procedure development
Technical problem-solving