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Lead Specialist, Parenteral Fill/Finish OJT

Lilly3d ago
United StatesOnsiteFull-timeEntry Level1+ yrs exp

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 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. Position Overview: The Parenteral (PAR) OJT role 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 and training of the facility.

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

Responsibilities

  • Integrity
  • The technician is responsible for implementing the operator training program.
  • May be involved in orienting new employees to the department, assess skills and competencies for all operators, coordinate OJTs to close skill gaps, provide on-the-job feedback to reinforce training
  • assess documents or systems that the operators utilize to perform their jobs for improvement opportunities.
  • Will qualify other instructors within operations and determine a re-qualification strategy.
  • Is instrumental in revision of key procedures / training courses in order to make them more user friendly and better understood by operators.
  • The OJT Technician is responsible for understanding and communicating changes to documents (Forms, Tools and Templates) prior to their effective date.
  • Responsible for key training metrics and reporting of operator training percent.
  • Assists supervision with identifying appropriate duty curriculum assigned to job codes.
  • Maintain printed document logbooks. 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.
  • 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 Requirements:
  • A minimum of one year GMP/Pharma experience
  • High School Diploma or GED Additional Skills/Preferences:
  • Skills in giving and receiving feedback
  • Basic computer skills (excel, word) are required
  • Ability to use respirator protection required
  • Technical growth & application
  • Self-management skills
  • Teamwork/Interpersonal skills
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Leadership and the ability to train/educate team members
  • Aseptic filling, single use assemblies, isolator technology.
  • 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.
  • Highly automated equipment (inspection, packaging, filling, assembly, etc)
  • SAP, Electronic Batch Records Additional Information:
  • 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.
  • Ability to work in a clean room with the appropriate gowning required
  • Primary location is Kenosha County, Wisconsin.
  • Ability to travel (approximately 10%) 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. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $25.96 - $38.08 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k)
  • vacation benefits
  • eligibility for medical, dental, vision and prescription drug benefits
  • 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
  • and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Required skills

GMPPharmaAseptic fillingSingle use assembliesIsolator technologyGood Manufacturing PracticesManufacturing Execution SystemsSAPElectronic Batch Records
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