Job Details
Equipment Qualification Lead
JO-2311-525372
Posted: 06/11/2023
- €65 - 80 per hour
- Republic of Ireland, Limerick
- Contract
Kenny-Whelan (a specialist division of the CPL group) are hiring an Equipment Qualification Lead to work on contract, supporting our US Biopharma clients new build biotech manufacturing facility in Raheen Limerick
Contact Jenn Dinan on 0860466583 or email jdinan@kenny-whelan.ie
Equipment Qualification Lead
Ltd contract role- 18 months initially
70-80p/h Pay rate
Overview:
We are 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 our 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 Lead to support our new Biologics Manufacturing Facility at Raheen Co. Limerick. The Equipment Qualification Lead is responsible for all aspects of qualification and operations of all temperature controlled units (TCUs).
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.
• 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.
• Influence the overall design of the Organisation, taking into account cross functional interactions.
Educational/Experience Requirements BSc/MSc Engineering or related discipline with a minimum of 5 years pharmaceutical experience.
All applications will be treated with the strictest of confidence.
Contact Jenn Dinan on 086046658
