- 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 Associate Dir, Manufacturing/Process
- Engineers who will give advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved.
This is a list of Core Duties and must not be taken as a definitive list.
- 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.
- Working to the ASME BPE 2016 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 for Validation activities and Engineering support during qualification.
- 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.
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.
- Good communication and Interpersonal skills required to operate in a multi-function project team set up.
- Ability to work within a team using your own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project.
- Good team leading skills and ability to work closely with other areas/departments within an organization.