Lead Operator - Aseptic Filling (Day Shift)

LillyConcord, NC
$26 - $38Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Requirements

  • 5+ years of experience working with automated equipment in a GMP/cleanroom environment
  • Leadership experience and the ability to train / educate team members
  • 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).
  • Integrity
  • Must be able to work B shift (6pm to 6am on 2-2-3 schedule)
  • Must Pass a “fitness for duty” physical exam
  • 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 (team coursework such as classes through RCCC).
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

  • STEM degree or certification
  • Knowledge of aseptic filling, single use assemblies, isolator technology.
  • Automated, semi-automated, and/or manual inspection experience.
  • 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

Responsibilities

  • Support start up activities required to bring the aseptic isolator barrier filling area into service.
  • Become the experts within their assigned area and educate their team in the proper operation of the facility.
  • Become the leaders for the PAR equipment and process and will lead the training of new staff.
  • 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.
  • Coordinate daily activities to meet capacity plans while developing their own and our team’s capabilities.
  • 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.
  • Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop 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.
  • Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
  • Assist Supervisor in development and performance evaluations of shift operators. Act as backup for Supervisor.
  • Key liaison between operations and support functions.

Benefits

  • 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
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance
  • 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)
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