Key Responsibilities:

Project Leadership

• Lead and coordinate cross-functional teams to deliver processing equipment, ensuring projects are completed within scope, timeline, and budget. Equipment includes packaging, inspection, assembly equipment, autoclaves, RABS, Isolator filling machines, LAF units, compounding skids, and vessels.
• Develop, review, and manage User Requirement Specifications (URS).
• Perform vendor selection and evaluation, managing the entire vendor relationship.
• Prepare and review RCEs, manage orders, and facilitate design review and project management meetings.
• Ensure compliance with industry standards (ASME BPE 2019, ISPE guidelines, etc.) throughout the project lifecycle.
• Manage the installation of processing equipment and oversee the connection of services, working closely with equipment vendors and internal engineering teams.
• Lead the Factory Acceptance Testing (FAT) process and coordinate all necessary documentation.
• Support commissioning and qualification activities, collaborating with cross-functional teams to ensure the project’s success.
• Oversee handover procedures, including training, O&M manuals, spare parts, and preventive maintenance schedules.

Product Development & Process Improvements:

• Actively contribute to technical problem-solving in the areas of product manufacturing and aseptic filling.
• Identify and drive process improvement initiatives and cost reduction projects.

Meetings & Reporting:

• Lead regular project review meetings with your project team to track progress and address any concerns.
• Participate in bi-weekly Engineering & Technology Tier 2 meetings with the Senior Manager of Engineering.

Education & Experience:

• Bachelor’s degree in Engineering or related discipline (or equivalent experience).
• Minimum of 2-5 years’ experience working in the Biologics, Pharmaceutical, or Medical Device industry.
• Proven track record in project management, with demonstrable success in delivering complex projects on time and within budget.
• Strong technical background with the ability to work independently and collaborate effectively with cross-functional teams.
• Excellent communication and interpersonal skills, with the ability to work in a multi-functional team environment.

Key Skills & Competencies:

• Strong leadership skills with the ability to motivate and guide team members.
• Problem-solving and decision-making abilities, with a focus on practical and efficient solutions.
• Well-organized, able to plan and prioritize tasks effectively.
• Ability to adapt to a fast-paced, changing environment while meeting deadlines.
• High level of energy and passion for delivering results.
• Open to receiving and acting on constructive feedback.
• Ability to build strong working relationships with stakeholders at all levels.

Additional Information:

Occasional travel (up to 4 times per year) may be required for design review meetings, build inspections, Factory Acceptance Tests (FAT), etc.

This is an onsite role based in Westport.

If you're passionate about working in a collaborative environment and leading impactful projects in aseptic processing and automation, we'd love to hear from you! Apply below or contact Róisín Vaughan at 086 440 3742.