Project Engineer Team Horizon is seeking a Project Engineer for a client in Mayo.
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.
Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing: People 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.
Product Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
Deliver on Process improvement / cost reduction projects Meetings Lead your regular weekly / bi-weekly Project review meetings with your Project team.
Attend the weekly Tier 1 meeting with your manager.
What you need to apply: 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.
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.
Behaviours/Value: Relationship Building: Establishing working relationships with main contacts through a hands on approach and giving clear and concise instruction.
Communication: Good communication and presentations skills, both written and oral ability to present data in a clear and concise manner to team members and where required, to management.
Planning & Organising: Able to plan activities and tasks whilst ensuring the required number of people are available and in place to perform the task.
Decision Making: Identify and understand issues, problems and opportunities whilst working within a team environment to provide a solution.
Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
Passion for results: Drive, high energy, and ability to work under pressure and deliver results; get things done (an action-oriented approach) overcome obstacles.
Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback.
Culture fit Have a people centred approach in a team environment whilst upholding the values and ethos of the company.
Other requirement (i.e.
travel) Undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FATs) etc.
Skills: project engineering equipment tech transfer project management