GerTEK is an engineering consultancy company specialising 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 in us to deliver their most strategic and important projects.
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.
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.
Why you should apply: Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
You enjoy working in a culture of learning and collaboration and making a positive impact.
What you will be doing: 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.
All other duties as requested or assigned.
What you need to apply: 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.
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.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.
If you are a motivated Senior Project Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.
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