Our client, based in Co. Waterford, is looking for a Construction Manager to join their pharmaceutical facility.
The Construction Lead / Manager will be responsible for the overview of several projects at the site in Waterford – primarily civil / structural related projects.
Core Duties and Responsibilities: The main area of work is to own and deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification.Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Lines which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.Support commercial manufacturing through delivery of key performance metrics (SQDCI).Support and participation in Regulatory Audits.Education & Qualifications Required: Degree in an Engineering discipline.Strong problem-solving skills.Strong documentation/protocol generation and execution skills.5-7 years' relevant experience working on pharmaceutical projects within a highly regulated GMP environment.Experience in syringe filling would be a distinct advantage.Ability to lead major investigations.Fill Weight Cycle Development experience for a filling machine.New product introduction experience to a sterile manufacturing area.Beneficial but not Essential: Full automatic filling line technology experience.Experience with various forms of filtration and associated filter integrity testing.Experience in sterile manufacturing.New product introduction experience.Experience with tending and data analysis of filling machine/ancillary equipment using historian software.
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