Project Engineer - Finished Goods, Api

Asset Recruitment

Dublin

Project Engineer - Finished Goods, API, and Engineering. Pharmaceutical. Job summary: Transfer and integration of new products from the development phase into production and launch. Transfer and integration of new product solutions of devices and primary packaging solutions from early phase development all the way to launch. Major science based improvements of manufacturing processes. Transfer of production to external partners. Main Duties: • Lead assigned engineering activities supporting the implementation/tech transfer of new products including scale-up from pilot scale/concept development to production scale manufacture. • Perform peer review and approval of MSAT NSE reports, specifications, risk assessments and protocols. • Coordinate/support SOS/MSAT NSE strategic initiatives as required. This will require preparation of project briefs, project plans, reporting, and handle meetings and follow up. • To support compliance with safety and GMP standards in MSAT NSE. • To promote interdepartmental liaison and co-operation. • To act as senior MSAT NSE SME supporting the development of departmental procedures and processes. • To assess the requirement for the execution of investigational testing/characterisation trials to support the implementation of the proposed engineering solutions and ensure timely execution and reporting. • To evaluate and ensure suitable control strategies /mitigations are in place to support proposed changes to engineering processes/ manufacturing equipment/packaging in relation to product quality, safety and manufacturing. Experience Required: • The candidate shall have an engineering degree ideally backed by project management training and 7 years of relevant project engineering experience (preferably related to NPI, bulk, filling and packaging. • Demonstrated experience of initiating, scoping & delivering medium to large engineering projects associated with NPI. • A good understanding of the pharmaceutical industry including GMP and regulatory requirements. • Demonstrated analytical and problem solving skills, ability to handle multiple tasks in a timely manner. This job originally appeared on RecruitIreland.com.

2324 days ago