LSC require a Technical Operations Engineer for a Biopharmaceutical Client in the Cork area for a 12 month contract. As part of the TO Team and reporting to the TO Director, the successful candidate will have a focus upon: Continued Process Verification/Process Validation/Process Improvements/Leading complex cross functional investigations/Standards and new technology deployment. The role will support Product Segmentation Projects. This is an urgent requirement, with our client requesting a start date as soon as is possible
Main Duties & Responsibilities
Life Cycle Management
– Manage / execute the validation program related to LCM for post stage gate 12 products
– Issue / review validation plan, protocols and reports
– Be the site TO representative in LCM/NPI project teams as process / validation SME
– As required coordination of LCM projects on site, under responsibility of global TO organization
– Technology & product technical life cycle management
– Own / participate in the CPV program by issuing plans, protocols and reports and oversee the execution.
– Lead complex investigations on the site by providing technical expertise
– Provides process / technology input to SOP’s, Master Batch Records and change controls
– Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
Innovation & Standardization
– Identify / lead / contribute to process improvement projects, including new technology / analytics introduction (e.g. PAT, MVA)
– Contribute to Standardization initiatives for Technical Operations
Inspection Readiness and Execution
– Technical support / direct participation in partnership with Quality / Operations on any regulatory audits and inspections
– Strong expertise on pharmaceutical manufacturing (Small Molecule API) processes and equipment, specifically for the applicable technology platform
– Project management (FPX or other) – team member / project lead
– Process excellence (6 sigma), lean concepts and statistical skills
– Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform.
QUALIFICATIONS & EXPERIENCE
– Essential: University degree in Engineering or Science, with minimum 5 years’ experience in a pharmaceutical environment AND/OR an equivalent combination of education and experience in:
– API Manufacturing and Purification for small/large molecules
– Quality Assurance and Regulatory
Desirable: Master Degree or Equivalent with 5 – 8 years’ experience in a pharmaceutical environment.
Please contact Ruth today for further details on 0214777329, or apply direct with an up to date CV in Word format via this advert.