PROJECT ENGINEER
The Project Engineer is responsible for safely coordinating and leading projects associated withNew Product Introductions, Process Improvements, Automation, Aseptic processing, NewProcessing equipment with some Facility / utilities modifications to incorporate same. Theprimary responsibility of the role is to ensure that Projects meet agreed goals/targets on timeand on budget. The E&T Engineer reports directly to the Senior Manager of Aseptic Engineeringwho will give advice and support to ensure the equipment/facility/utilities design andgoals/targets are achieved.
Responsibilities:
1. 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.
2. Writing User Requirement Specifications.
3. Selecting Vendors and completing Vendor evaluation matrix.
4. Writing RCE's, placing orders, Project Management & Design review meetings.
5. Working to the ASME BPE Standard and relevant ISPE Guidelines etc.
6. Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.
7. Lead the Project Team participation in Factory Acceptance Testing program.
8. Coordination of all equipment documentation requirements.
9. Commissioning of equipment and Engineering support during qualification.
10. Work with the E&T Senior Manager & System Owner / Project Team.
11. Handover training, coordination of O&M manuals, Spare parts, & PM schedules.
12. Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
Requirements:
13. Third level qualification in an Engineering or equivalent discipline/experience.
14. Experience of working in Biologics, Pharmaceuticals or Medical device industry. Minimum of 2 to 5 years' experience.
15. Project Management experience with a proven record.
16. Assured self-starter with proven Technical ability.
17. Good communication and Interpersonal skills required to operate in a multi-function project team set up.
18. 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.
19. Good team leading skills and ability to work closely with other areas/departments within an organization.
#LI-MS2