Project Engineer

4 weeks ago

Ballina, Mayo County, Ireland Gertek Project Management Full time
Location - Westport, Mayo Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
PROJECT ENGINEER: The Project Engineer is responsible for safely coordinating and leading projects associated with New Product Introductions, Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility / utilities modifications to incorporate same.
The primary responsibility of the role is to ensure that Projects meet agreed goals/targets on time and on budget.
The E&T Engineer reports directly to the Senior Manager of Aseptic Engineering who will give advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved.
Responsibilities: Safely coordinate and lead cross functional project teams for the delivery of processing equipment to the site based on planned timelines and scope.
Processing equipment would include e.g., Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding skids, Vessels, Containment booths & Stopper processing eq.
Writing User Requirement Specifications.
Selecting Vendors and completing Vendor evaluation matrix.
Writing RCE's, placing orders, Project Management & Design review meetings.
Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc.
Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.
Lead the Project Team participation in Factory Acceptance Testing program.
Coordination of all equipment documentation requirements.
Commissioning of equipment and Engineering support during qualification.
Work with the E&T Senior Manager & System Owner / Project Team.
Handover training, coordination of O&M manuals, Spare parts, & PM schedules.
Requirements: Education and Experience/Knowledge: Third level qualification in an Engineering or equivalent discipline/experience.
Experience of working in Biologics, Pharmaceuticals or Medical device industry.
Minimum of 2 to 5 years' experience.
Project Management experience with a proven record.
Assured self-starter with proven Technical ability.
Other requirement (i.e.
travel) Undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FAT's) etc.
Employment type - Full-time Work location - Onsite (In-person) To start the process click the Continue to Application or Login/Register to apply button below.

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