Equipment Project Engineer

R Dpartners; Munster; On-site; EUR 41,000 - 55,000; Full time

Job summary

R&D Partners is seeking an experienced Equipment Project Engineer to join a leading biotechnology company in ROI. The role is onsite and contract-based, offering involvement in high-impact GMP projects within a regulated environment.

The position requires strong project management, deep GMP knowledge, and the ability to lead cross-functional teams including contractors and vendors. Right to work in Ireland is mandatory.

Qualifications

• Experience managing GMP equipment and facility upgrade projects.
• Strong knowledge of GMP/GDP standards and regulatory compliance.
• Ability to coordinate multi-stakeholder teams and contractors.

Responsibilities

• Manage all aspects of assigned projects including schedule, cost, scope, safety, quality and regulatory compliance.
• Lead design management to meet user requirements and GMP standards.
• Coordinate meetings, document outcomes and ensure timely action closure.
• Oversee contractor and OEM performance to meet quality and schedule expectations.
• Collaborate with Document Control for timely project documentation.
• Provide regular project status updates and deliver performance metrics.

Job description

Are you an experienced Project Engineer ready to lead complex equipment and facility upgrades that support the future of biotechnology manufacturing?

R&D Partners is seeking an experienced Equipment Project Engineer to join a leading biotechnology company in ROI. This fully onsite contract role offers an exciting opportunity to contribute to high-impact projects within a regulated GMP environment.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Manage all aspects of assigned projects, including schedule, cost, scope, safety, quality, and regulatory compliance.
• Lead design management and ensure adherence to user requirements and GMP/GDP standards.
• Coordinate project meetings, document outcomes, and ensure timely action closure.
• Oversee contractor and OEM performance to meet quality, schedule, safety, and GMP expectations.
• Collaborate with Document Control for timely submission of project documentation.
• Perform procurement activities, equipment acceptance, and infrastructure delivery while providing regular project status updates.
• Ensure compliance with environmental health and safety codes, KPIs, and performance standards.
• Liaise with internal and external stakeholders, suppliers, and vendors for seamless project execution.
• Mentor project team members and maintain accurate project planning documentation.
• Provide weekly progress reports to management and senior stakeholders.
• Review engineering deliverables, initiate change controls, and manage project lifecycle documentation.
• Deliver performance metrics for budget, schedule, scope, and quality adherence.

Key Skills and Requirements:

Project Management:

• Expertise in project planning, scheduling, budgeting, and risk management.
• Ability to manage complex, multi-stakeholder projects within a regulated environment.

Technical Skills:

• Experience with production equipment qualification and GMP facility upgrades.
• Strong understanding of aseptic processing, contamination control strategies, and cleanroom design principles.
• Familiarity with cleanroom classification standards (ISO 14644, EU GMP Grades A-D).
• Knowledge of qualification and validation lifecycle, including CSV, equipment qualification, and cleaning validation.
• Understanding of HVAC systems, pressure cascades, and environmental monitoring requirements.
• Proficiency in MS Office and project management software.

Leadership & Communication:

• Proven ability to lead cross-functional teams and coordinate contractors in a GMP setting.
• Strong analytical, problem-solving, and decision-making skills.

Safety & Compliance:

• Ensure all works are planned and executed safely under Safe Systems of Work.
• Support Construction and Area Management teams for safe execution in GMP-controlled environments.
• Ensure full compliance with GMP, GDP, and Change Control processes.
• Support regulatory inspection readiness and audit preparation activities (FDA, EMA).

Validation & Qualification Coordination:

• Collaborate with CQV teams for equipment and facility qualification activities.
• Attend FATs and draft/review protocols and reports.

Salary:

• €30.00 – €40.00/Hour

For more information, please contact Grant Van Schalkwyk.