LSC have a great opportunity for a C&Q Engineer to join a leading pharmaceutical company in Cork. Our client specialises in the manufacture of small molecule APIs in three production facilities on site, one of which is sterile. This site has been producing APIs for over 35 years in Cork and has developed a reputation as being innovative, adaptive, and having a clear strategic vision. The site has added to its core functions over the years and is now a key decision maker in the company's global supply chain. If you have previous C&Q Experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
* Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
* Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
* Prepare C&Q protocols as required (e.g. URS's / SRS's, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
* Review and approve documents prepared by contractor organisations (e.g. vendor SAT's, FAT's, commissioning protocols, project change controls/notifications).
* Execute C&Q protocols as required.
* Co-ordinate C&Q activities with project engineering, construction and site operations activities.
* Co-ordinate C&Q activities with contractors and vendors as required.
* Co-ordinate C&Q document reviews and approvals.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* Minimum 5+ years' experience in the Pharmaceutical (API) Industry - specifically bulk API - non negotiable. Supporting various capital projects onsite from a C&Q perspective. Preparing C&Q protocols and executing those in the field.
* Experience of commissioning and qualifying some of the following systems:
Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / grey utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
* Experience preparing and executing commissioning and qualification protocols and reports.
* Knowledge and experience of Project Delivery Processes (PDP).
* Knowledge and experience of current Good Engineering Practices (GEP).
Note: Mainly onsite, potential for 1 day a week hybrid
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!
Call Sarah Ninan in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert
