Project Lead
The Project Lead is responsible for safely coordinating and leading cross-functional project teams to deliver processing equipment to the site based on planned timelines and scope.
* Safely coordinate and lead cross-functional project teams for the delivery of processing equipment to the site based on planned timelines and scope.
* 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.
Main Responsibilities:
* The primary responsibility of the role is to ensure that Projects meet agreed goals/targets on time. 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.
* Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
* Deliver on Process improvement/cost reduction projects.
Main Contacts:
* Senior Manager Engineering, Equipment Vendor, Quality Leads, Validation Engineers, Operation Leads, Technology Leads, Maintenance technicians, Business Technology Technician, EHS Engineers.
To be successful in this role, you will need:
* A third-level qualification in an engineering discipline or equivalent experience.
* Experience of working in Biologics, Pharmaceuticals, or Medical device industry.
* A minimum of 2-5 years' experience.
* Project Management experience with a proven record.
* An assured self-starter with proven technical ability.
* Good communication and interpersonal skills required to operate in a multi-function project team set-up.
* The 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 organisation.
* The ability to undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FATs) etc.