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