Lead Specialist, Parenteral Fill/Finish OJT

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.

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, and 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
• A 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%)