Orion Group Life Sciences is currently recruiting a Project Engineer on behalf of our multinational biopharmaceutical client based in Mayo. This is an initial 12-month contract with the potential for extension.
Job Summary
The Project Engineer is responsible for safely coordinating and leading projects related to New Product Introductions, Process Improvements, Automation, Aseptic Processing, and new processing equipment, with some facility/utilities modifications. The primary goal is to ensure projects meet their targets on time and within budget. The E&T Engineer reports directly to the Senior Manager of Aseptic Engineering, who provides guidance and support to achieve equipment, facility, and utility design goals.
Responsibilities:
1. People
* Coordinate and lead cross-functional project teams for the delivery of processing equipment based on planned timelines and scope, including autoclaves, RABS, isolator filling machines, LAF units, and other equipment.
* Write User Requirement Specifications.
* Select vendors and complete vendor evaluation matrices.
* Prepare RCEs, place orders, and conduct project management and design review meetings.
* Work in accordance with ASME BPE 2019 standards and relevant ISPE guidelines.
* Coordinate installation and hookup of processing equipment with vendors and engineering personnel.
* Lead participation in Factory Acceptance Testing (FAT).
* Manage all equipment documentation requirements.
* Support commissioning and qualification activities.
* Collaborate with the E&T Senior Manager and project team.
* Coordinate handover training, O&M manuals, spare parts, and preventive maintenance schedules.
1. Product
* Contribute to technical problem-solving forums related to product manufacture and aseptic filling.
* Deliver process improvement and cost reduction projects.
1. Meetings
* Lead weekly or bi-weekly project review meetings with the project team.
* Attend weekly Tier 1 meetings with the manager.
Requirements:
Education and Experience/Knowledge:
* Third-level qualification in engineering or equivalent discipline/experience.
* Experience in biologics, pharmaceuticals, or medical devices, with 2-5 years of relevant experience.
* Proven project management experience.
* Self-starter with strong technical skills.
* Good communication and interpersonal skills for multi-functional team collaboration.
* Ability to work independently and as part of a team, articulating and delivering functional requirements.
* Strong team leadership skills and ability to collaborate across departments.
Other requirements (e.g., travel):
* Willingness to undertake travel for design reviews, build inspections, FATs, etc.
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