Location – Westport, Mayo

GerTEK 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)