The Project Engineer is responsible for coordinating and leading projects focused on process improvements, automation, aseptic processing, and new processing equipment, as well as facility/utilities modifications. The role ensures that projects are delivered on time, within scope, and on budget. Reporting to the Senior Manager of Engineering, the Project Engineer will work closely with cross-functional teams to achieve design goals and project targets.
Key Responsibilities:
* Lead cross-functional teams in the delivery of processing equipment (e.g., packaging, assembly, inspection equipment, autoclaves, RABS & isolator filling machines, LAF units, compounding skids, vessels).
* Develop and write User Requirement Specifications (URS).
* Select vendors and manage the vendor evaluation process.
* Oversee project management tasks, including writing RCEs, placing orders, and conducting design review meetings.
* Ensure compliance with ASME BPE 2019 standards and ISPE guidelines.
* Coordinate installation, service hook-up, and commissioning of processing equipment, collaborating with equipment vendors and engineering teams.
* Lead the Factory Acceptance Testing (FAT) process.
* Manage equipment documentation and provide engineering support during equipment qualification.
* Work closely with the E&T Senior Manager, system owners, and project teams to ensure successful project completion.
* Organize handover training, manage O&M manuals, spare parts, and PM schedules.
Product & Process Improvement
* Contribute to technical problem-solving forums related to product manufacturing and aseptic filling.
* Drive process improvement and cost reduction initiatives.
Meetings & Reporting
* Lead weekly/bi-weekly project review meetings with your team.
* Attend bi-weekly E&T Tier 2 meetings with your manager.
Key Requirements:
Education & Experience
* Third-level qualification in Engineering or a related discipline, or equivalent experience.
* 2-5 years’ experience in the biologics, pharmaceuticals, or medical device industry.
* Proven project management experience with a strong technical background.
* Excellent communication and interpersonal skills for effective collaboration within cross-functional teams.
* Ability to lead teams and work independently to deliver project requirements across various disciplines.
* Relationship Building: Develop strong working relationships through hands-on collaboration and clear instructions.
* Communication: Strong written and oral communication skills, able to present data clearly to team members and management.
* Planning & Organizing: Skilled in planning and organizing tasks and ensuring the right resources are in place for execution.
* Decision Making: Identify and address issues or opportunities and collaborate within a team to provide solutions.
* Adaptability: Thrive in a fast-paced, dynamic environment and adjust to meet unexpected challenges.
* Passion for Results: High energy, resilience, and the ability to deliver results under pressure.
* Receptivity to Feedback: Open to new ideas and constructive feedback.
* Culture Fit: Demonstrate a people-centered approach, aligning with the company’s values and ethos.
Other Requirements:
* Occasional travel may be required for design reviews, build inspections, and Factory Acceptance Tests (FATs), up to 4 times per year based on business needs.
* The role is based on site in Westport.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Project Management and Engineering
Industries
Pharmaceutical Manufacturing
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