Equipment Qualification Site Lead

Description:

Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

Responsibilities

We are seeking an Equipment Qualification Site Lead to support our new Biologics Manufacturing Facility at Raheen Co. Limerick. The Equipment Qualification Site Lead is responsible for all aspects of qualification and operations of all temperature controlled units (TCUs). They will develop the start-up strategies, influence the organisation structure and transition into supporting execution of control strategies in the manufacturing facility at Raheen, post start up.

Key Responsibilities

Role will initially support start up activities with design of strategies for temperature control units (TCUs) e.g. walk in and upright freezers, cold rooms, working cell bank, incubators, lab freezers, as required.

Post start up, the role will transition into a Custodian role ensuring daily execution and management of temperature controlled storage areas in the Limerick facility.
 

• User rep for design and operation of all temperature-controlled units (TCUs) in the Limerick site.
• Design control strategy including alarm rationalisation, monitoring and response for all temperature-controlled storage areas.
• Interact with Development to influence early molecule storage considerations for manufacturing.
• Support Mapping Studies to ensure temperature mapping is integrated into control strategy for required product interactions movement e.g. shipping, unloading and loading freezers
• Define the business processes for temperature-controlled unit interactions including work instructions, procedures etc
• Support FMEAs, safety risk assessments, Job Hazard Assessments on introduction of walk-in freezers / cold rooms
• Work with business partners, procurement and vendors to build robust SLAs and develop preventative maintenance programme for onsite TCU’s
• Design & influence paperless system for product movements to ensure all moves are executed according to while maintaining paperless approach.
• In conjunction with Automation/IT Team, support the design of interactive user dashboards to monitor and trend alarms / performance.
• Design and own BCP for temperature control units, site wide.
• Influence the overall design of the Organisation, taking into account cross functional interactions.

• Post start up activities will include:
  • Custodian for Temperature Controlled Storage areas across Limerick site
  • Execution of alarm strategy including ongoing monitoring and alarm response for both TCUs
  • Support deviation & change management, where applicable.
  • Provide front line inspection support for TCU qualification, control strategy and alarm parameters and qualification

Educational/Experience Requirements
 

• BSc/MSc Engineering or related discipline with a minimum of 5 years pharmaceutical experience.