Project Manager Role
Our organization specializes in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust us to deliver their most strategic and important projects.
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.
* Develop User Requirement Specifications.
* Select vendors and complete Vendor evaluation matrices.
* Write Request for Capabilities Evaluations (RCEs), place orders, hold Project Management & Design review meetings.
* Work to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc.
* Coordinate processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.
* Lead the Project Team participation in Factory Acceptance Testing programs.
* Coordinate all equipment documentation requirements.
* Commission equipment and provide engineering support during qualification.
* Collaborate with the E&T Senior Manager & System Owner / Project Team.
* Provide handover training, coordination of O&M manuals, Spare parts, & PM schedules.
Requirements:
* 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.
* Self-motivated individual with proven technical ability.
* Other requirement: undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FATs) etc.