Project Engineer (Aseptic Pharma) in Westport

Westport, Co. Mayo, Ireland

Who We are: NIRAS Ireland provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally.

Opportunity: We are now recruiting a Process Project Engineer to join our client’s high performing Engineering team in Westport Co. Mayo. The successful candidate will join a team of 6, reporting to the Sr. Manager and be responsible for a portfolio of small-large sized projects (20K to 15 million) related to new equipment/technologies and/or upgrades. This is a cross-functional role - supporting Operations, EHS and Quality departments and managing 5-6 projects at any one time from cradle to grave. Projects may include installation of automated packaging lines or other equipment onsite; overseeing/securing funding, selection of vendors, installation (C&Q, validation, handover to relevant department).

Job Role Purpose: The Project Engineer is responsible for safely coordinating and leading projects associated with Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility/Utilities Modifications. The primary responsibility of the role is to ensure that Projects meet their agreed goals/targets on time and on budget. The Project Engineer reports directly to the Senior Manager of Engineering who will provide advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved.

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., Packaging equipment, Assembly Equipment, Inspection Equipment, Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding Skids, Vessels etc.
• 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.
• 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 regular weekly/bi-weekly Project review meetings with your Project team.
• Attend the twice weekly E&T Tier 2 meeting with your manager.

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 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.

Other requirements (i.e. Travel): Be prepared to undertake any travel that the role may require for design review meetings, build inspections, Factory Acceptance Tests etc. This will be ad-hoc (0-4) times per year depending on business requirements.

Candidate Profile: Ideally seeking candidates holding qualifications in Mechanical/Electrical/Mechatronic Engineering with at least 3 years’ experience in a Pharma/Med Device Project Engineering or Process Engineering role with proven project management experience in a regulated manufacturing environment. Candidates will be working in a dynamic role - candidates must be self-driven, able to multi-task several projects and prioritise deliverables. Good understanding of assembly and processing equipment as well as facility/utility knowledge. Aseptic knowledge is not essential but a bonus.