LSC have a great contract opportunity for an Equipment Qualification Lead to join a based Biotech Drug Substance Manufacturing Facility. 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.
If you have at least 5 years relevant experience in a cGMP environment and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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.
- Influence the overall design of the Organisation, taking into account cross functional interactions.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Requires BSc/MSc Engineering
- At least 5 years relevant experience in a cGMP environment is required
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Sarah Ninan at LSC on 021-4777329, if you have any more questions about this opportunity!