Equipment Project Engineer – Production Equipment

Join a cutting-edge biopharmaceutical operation where your project leadership will shape the future of manufacturing, automation, and facility excellence.

R&D Partners is seeking an experienced Equipment Project Engineer to manage and deliver a diverse portfolio of projects within a biopharmaceutical manufacturing environment. This role will support operations across enzyme, monoclonal antibodies (mAbs), medical device, laboratory, and packaging areas. The successful candidate will oversee all aspects of project management, ensuring adherence to schedule, cost, quality, safety, and scope from conception to completion. Assigned projects will be part of a multi-million-euro capital portfolio.

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

Responsibilities:

General:

• Manage all elements of assigned projects, including schedule, cost, scope, safety, quality, and regulatory compliance.
• Lead design management and ensure compliance with scope, user requirements, and GMP-GDP standards.
• Oversee contractor and OEM performance to meet quality, schedule, safety, and GMP expectations.
• Coordinate with Document Control for timely submission of project documentation.
• Perform procurement activities, equipment acceptance, and infrastructure delivery while reporting regularly on project status.
• Ensure compliance with environmental health and safety codes, KPIs, and performance standards.
• Liaise with internal and external stakeholders, suppliers, and vendors to ensure right-first-time project delivery.
• Provide weekly progress reports to management and senior stakeholders.
• Review engineering deliverables, initiate change controls, and manage documentation throughout the project lifecycle.

Schedule Management:

• Identify, record, and communicate delays through formal change control processes.
• Lead schedule workshops and proactively challenge contractors to maintain milestones.

Scope & Cost Management:

• Develop and maintain URS-URB documentation.
• Control scope and cost changes through formal change processes.
• Align budget and schedule with scope requirements to prevent scope creep.

Safety:

• Ensure all works are planned and executed safely under Safe Systems of Work.
• Support Construction and Area Management teams to ensure safe execution within GMP-controlled environments.

Quality & Regulatory Compliance:

• Ensure full compliance with GMP, GDP, and Change Control processes.
• Support risk assessments for GMP-impact areas, including cleaning validation and sterility assurance.
• Coordinate with Quality Assurance for deviation management and CAPA implementation.
• Support regulatory inspection readiness and audit preparation activities (FDA, EMA).

Validation & Qualification Coordination:

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

Key Skills and Requirements:

Technical Skills:

• 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.

Project Management Skills:

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

Leadership & Communication:

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

Education & Experience:

• Degree in Process, Mechanical, Chemical, Industrial, or equivalent Engineering discipline.
• Minimum 5 years of project management experience and 5-10 years of delivering engineering projects in pharmaceutical or biotech GMP environments.
• Detailed knowledge of cGMP environments with strong automation experience.
• Experience supporting FDA or EMA inspections is desirable.
• A Master’s degree is an advantage.

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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