Biopharma Equipment Project Engineer — GMP & Qualification

Tandem Project Management Ltd.; Waterford; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Tandem Project Management Ltd. in Waterford is seeking an experienced Equipment Project Engineer to lead a diverse portfolio within a biopharma manufacturing setting.

You will plan, forecast, and manage all project activities to ensure schedule, cost, quality, safety and scope from conception to completion. Assigned projects form part of a multi-million-euro capital portfolio, with exposure to enzyme, mAbs, medical device, lab and packaging environments.

Qualifications

• Bachelor-level degree in engineering or equivalent.
• Master's degree is an advantage.

Responsibilities

• Manage all elements of assigned projects including schedule, cost, scope, safety, quality, and regulatory compliance.
• Lead design management and ensure GMP/GDP standards compliance.
• Lead project meetings with accurate documentation and timely actions.
• Manage contractor and OEM performance to meet quality, schedule and safety expectations.
• Coordinate with Document Control for timely submission of project documentation.
• Perform procurement activities, equipment acceptance, and infrastructure delivery, reporting status.
• Ensure cleanliness and environmental, health and safety compliance per KPIs and specs.
• Engage stakeholders to ensure right-first-time project delivery.

Skills

Project management

GMP/GDP compliance

cGMP environments

Regulatory compliance

Vendor management

Documentation control

Budgeting

Scheduling

Risk management

Production equipment

Qualification

CSV/validation

HVAC/environmental monitoring

PSCS responsibilities

MS Office

Project management software

Aseptic processing

Cleanroom design

Education

Degree in Process, Mechanical, Chemical, Industrial, or equivalent Engineering

Master's degree

Tools

MS Office

Project management software

Job description

Tandem Project Management Ltd. in Waterford is seeking an experienced Equipment Project Engineer to lead a diverse portfolio within a biopharma manufacturing setting.

You will plan, forecast, and manage all project activities to ensure schedule, cost, quality, safety and scope from conception to completion. Assigned projects form part of a multi-million-euro capital portfolio, with exposure to enzyme, mAbs, medical device, lab and packaging environments.