Technical Operations Engineer is required for 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. The site is going through a series of upgrades and investments in 2016/17 which will add to its current capabilities and strengthen its long term strategic plan.
The Technical Operations Engineer will be responsible for:
o Life Cycle Management
o Manage / execute the validation program related to LCM for post stage gate 12 products
o Issue / review validation plan, protocols and reports
o Be the site TO representative in LCM/NPI project teams as process / validation SME
o As required coordination of LCM projects on site, under responsibility of global TO organization
Technology & product technical life cycle management
o Own / participate in the CPV program by issuing plans, protocols and reports and oversee the execution.
o Lead complex investigations on the site by providing technical expertise
o Provides process / technology input to SOP’s, Master Batch Records and change controls
The Technical Operations Engineer requires:
o University degree in Engineering or Science, with minimum 5 years’ experience in a pharmaceutical environment
o And/or an equivalent combination of education and experience in
– API Manufacturing and Purification for small/large molecules . Quality
– Assurance and Regulatory
o Strong expertise on pharmaceutical manufacturing (Small Molecule API) processes and equipment, specifically for the applicable technology platform
o Project management (FPX or other) – team member / project lead
o Process excellence (6sigma), lean concepts and statistical skills
o Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform.
Call Kathy in LSC 021 4777 329 for more details on this new Technical Operations Engineer role or apply directly via this advert.