Project Engineer (Aseptic Pharma)

Project Engineer (Aseptic Pharma Manufacturing Environment)

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. Successful candidate will join a team of 6, reporting to 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. Cross-functional role - Will support Operations, EHS and Quality departments and be responsible for 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 to incorporate same. 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 give 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 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 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.

Min 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