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Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.
To facilitate bringing the plant on-line, several operational roles will be necessary to execute all the activities to start-up the facility, create multiple business processes, complete Process Validation, then assume day to day production activities.
The Supervisor provides leadership and direct supervision to the Production Operators at the Limerick site.
Initially, the Supervisor will be responsible for leading Operators and carrying out tasks associated with bringing the new facility on-line. After the plant is running, the Supervisor will be responsible for directing activities on their shift in alignment with production targets and leadership direction. The Supervisor is the management representative on shift.
Key Objectives/Deliverables:
In line with the job role outlined above, the following are typically the key tasks that would be expected of the Production Supervisor:
People Management
Responsible for individual’s performance, manage employee relations, 1:1 time.
Be a role model for personnel in terms of performance, behaviours.
Effectively assign tasks and completion criteria.
Work with other operations and support resources to assure all activities have adequate operator coverage to ensure production targets or milestones are met.
Follow and ensure adherence with vacation/absence/overtime policies.
Conduct thorough information pass downs to ensure the appropriate personnel are aware of all issues and progress made on tasks.
Lead teams as necessary to accomplish plant start-up and team goals.
Participate in any start-up activities, including IQ/OQ/PQ/PV/CV, procedure reviews, and training reviews.
Participate in Operator interviewing, on-boarding and deliver training
Compliance Culture
Help to promote a culture of quality and safety compliance within the area by demonstrating the desired behaviours.
Ensure that all operations personnel are adhering to the relevant compliance procedures.
Organise, participate in, and/or lead routine Quality and EH&S audits/inspections of the facility with operators and support personnel.
Ensure all required documentation are complete and accurate.
Maintain housekeeping standards within their assigned areas and the building in general.
Routine Production and Start-up
Run morning/ shift team meetings.
Escalate issues and barriers to start up and efficient execution of tasks where appropriate.
Co-ordinate immediate response to major Quality and EHS events in off – hrs, as necessary.
Assignment of operators to specific tasks for the day based on the production schedule or start-up milestones outlined at morning meeting.
Liaise with maintenance and other support teams to execute tasks. Work closely with technical support to ensure activities performed in a compliant manner.
Ensure production plan or start-up milestones are met.
Ensure all relevant documentation is completed by end of day/shift.
Basic Requirements:
Four years GMP manufacturing experience required.
Good communications skills (both oral and written).
Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
Good organization skills.
Ability to demonstrate attention to detail.
Additional Preferences:
Technical problem solving skills.
Strong Leadership skills.
Previous manufacturing Supervisor experience.
Education Requirements:
Leaving Certificate or equivalent education or experience.
Other Information:
During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 12 hours shifts.
Some overtime may be required.
The job specification 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 specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
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