Project / Process Engineer
Department: Engineering & Technology (E&T)
The Project / Process Engineer is responsible for safely coordinating and leading projects
associated with 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 meets their agreed goals/targets on time and
on budget. The E&T Engineer reports directly to the Assoc Dir, Manufacturing/Process
Engineering who will give advice and support to ensure the equipment/facility/utilities design and
goals/targets are achieved.
- 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, LAF units, Equipment upgrades,Lyophilsers, Isolators, Containment booths and Stopper processing equipment.
- Writing User Requirement Specifications.
- Selecting Vendors and completing Vendor evaluation matrix.
- Writing ACER’s, placing orders, Project Management & Design review meetings.
- 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 for Validation activities and Engineering support during
- Work with the E&T Manager & System Owner / Project Team for direction and advice / support on key project outcomes.
- Ensure handover training and co-ordinating of maintenance manuals, Spare parts,
O&M’s & PM schedules.
Contribute in a team environment on specific technical problem solving forums
associated with Product manufacture & Aseptic fill.
- Deliver on Process improvement projects which are known as Green Belt projects.
- Lead your regular weekly / bi-weekly Project review meetings with your Project team
- Attend the twice weekly E&T Tier 2 meeting with your Manager.
- 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.
- Good communication and Interpersonal skills required to operate in a multi-function project
team set up.
- Good team leading skills and ability to work closely with other areas/departments within an
- Relationship Building: Establishing working relationships with main contacts through a
hands on approach and giving clear and concise instruction.
- Planning & Organising: Able to plan activities and tasks whilst ensuring the required
number of people are available and in place to perform the task.
- Passion for results: – Drive, high energy and ability to work under pressure and deliver
results; get things done (an action-oriented approach); overcome obstacles.
- Culture fit: Have a people centred approach in a team environment whilst upholding the
values and ethos of the company.
- Undertake any travel that the role may require for design review meeting, build inspections,
Factory Acceptance Tests (FAT’s) etc.
For further information contact Sean on 094 90 29944.