Technical Engineering Manager
Fastnet The Talent Group
Cork
Fastnet The Talent Group are currently recruiting for a Technical Engineering Manager with a leading Pharmaceutical client based in Cork. Permanent Role, excellent opportunity for the right candidate. Job Purpose. The Technical Manager will support the MS&T organization by leading initiatives and/or work-streams and representing ESO MS&T in various global networks. This position will also be responsible for identifying and executing continuous improvement opportunities, leading New Product Launch technical teams and leading technical activities related to transfers of Chemicals, Drug Product Manufacture and Packaging. Major accountabilities include. The Technical Manager can be assigned to one specific role or combine several, depending on the size of his/her portfolio (e.g. Technical Manager - Product Steward, or Technical Manager - Transfer & NPL, etc. Providing MS&T intelligence to deviations, investigations, OOE's and OOS's, technical complaints. Defining and tracking technical CAPAs resulting from APR/PQR assessments or manufacturing variances. Providing MS&T intelligence to APR/PQR and delivering the performance capability results, interpretations and recommended CAPAs; Establishing and executing product revalidation strategies including approval of QRAs, validation protocols and reports. Establishing and executing continued process verification strategies and annual verification; ix) ensuring maintenance of knowledge for the manufacturing of NVS products. Product Transfers As transfer technical lead, the Technical Manager is responsible for the successful transfer of the manufacturing process (API, bulk DP and packaging) and its validation at the receiving site by ensuring subject matter risk assessment and excellence in execution. Requirements. BSc/MSc in a Scientific or Technical discipline. Preferably Chemical Engineering, Chemistry, Organic Chemistry PhD a plus. Extensive experience in a Pharmaceutical manufacturing/technical environment. Strong leadership skills with several years managerial experience. Demonstrated technical expertise in manufacturing science and drug development. Significant knowledge of industry practices and regulations (e.g. GxP, ISO, ICH / VICH, etc.) across multiple health authorities (e.g. FDA, EMEA, Health Canada, etc.) Statistical knowledge required, Lean/Six Sigma Certification preferred. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.
2323 days ago