Fantastic opportunity within a market-leading pharmaceutical company based in Limerick for a Process or Project Engineer with strong GMP experience.
Project Manager - Technical Transfer
Perm | Pharma | Limerick
As Project Manager, you will collaborate with MSAT groups in sister sites, to transfer manufacturing processes to their Limerick based site. You will focus on ensuring site to site consistency after the processes are successfully transferred. This role will require you to provide floor support during operations of manufacturing campaigns, review process data to ensure operational consistency and provide support for investigations.
Coordinate technology transfer activities, through collaboration with other departments and relevant stakeholders
Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities
Review technology transfer protocols and reports, manage document exchange ( SOPs, SPECs, validation, raw material and instrument qualification documents, batch records, etc.).
Provide process transfer support to external facilities, including generation of process descriptions and facility fit comparisons.
Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
Provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across manufacturing
Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
Provide and schedule floor support in the processing areas during manufacturing operations.
Lead special projects as assigned.
Level 8 / Bachelors Degree in Sciences or Engineering with 8+ years of relevant experience in a cGMP environment
A qualification in Project Management is desirable, but not essential
Ability to communicate clearly the timelines and important milestones
Ability to adapt to a quickly changing environment.
Solid knowledge of cGMP and other applicable regulations.
Ability to effectively communicate issues and ideas with peers and with management.
Ability to facilitate meetings with cross functional teams.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.