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.
Key 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.
* Deliver on Process improvement / cost reduction projects.
* Lead your regular weekly / bi-weekly Project review meetings with your Project team.
* Attend the weekly Tier 1 meeting with your manager.
* Liaise with Senior Engineering Manager, Equipment Vendor, Quality Leads, Validation Engineers, Operation Leads, Technology Leads, Maintenance technicians and Business Technology Technicians.
Requirements:
* Third level qualification in an Engineering or equivalent discipline/experience.
* Experience of working in Biologics, Pharmaceuticals or Medical device industry.
* Minimum of 3-5 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.
* Experience in commissioning and cycle development/Validation/startup would be a huge advantage, We are looking for someone with specific E&I experience for a vessel and control system.