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.
* Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
Requirements:
* 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.