Construction Project Manager

Role Purpose:

* 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.