Biopharma Process Engineer - Start-Up & PQ Specialist

EFOR; Limerick; On-site; EUR 80,000 - 110,000; Full time

Job summary

EFOR is seeking a Process Engineer for a biopharmaceutical plant in Limerick, Ireland. You will drive PSQ start-up activities, coordinate with the GFD Commissioning and Qualification Team, and support scheduling and delivery of the full PSQ programme to meet project milestones.

You will define PQ requirements, author PQ protocols for manufacturing equipment, help develop PQ schedules and sequencing, and participate in site meetings to ensure timely handover of utilities and equipment to the

Qualifications

• Bachelor’s degree in Engineering or Science (BSc/BE) or equivalent practical experience is required.
• Minimum of 5 years’ experience in commissioning and qualification of pharmaceutical equipment and utilities, ideally in a site start-up environment.
• Demonstrated proficiency with MS Project for scheduling and programme management.
• In-depth knowledge of GMP regulations, relevant regulatory requirements, and best practices for equipment commissioning and qualification.
• Experience with systems such as DeltaV (batch processing), Syncade MES, Kneat validation management, or SAP is highly advantageous.
• Strong written and verbal communication skills with the ability to engage effectively with both technical and non-technical stakeholders.

Responsibilities

• Support the development, scheduling, and delivery of the full PSQ programme, ensuring alignment with project management and milestones.
• Coordinate with the GFD Commissioning and Qualification Team for safe handover of utilities and equipment.
• Define PQ study requirements and author detailed PQ protocols for manufacturing equipment readiness.
• Play a key role in PQ schedule development by defining equipment groupings, sequencing, and durations for all PQ activities.
• Participate actively in site meetings and activities.

Skills

MS Project

GMP regulations

Communication

Education

Bachelor’s degree in Engineering or Science (BSc/BE) or equivalent practical experience

Tools

DeltaV (batch processing)

Syncade MES

Kneat validation management

SAP

Job description

EFOR is seeking a Process Engineer for a biopharmaceutical plant in Limerick, Ireland. You will drive PSQ start-up activities, coordinate with the GFD Commissioning and Qualification Team, and support scheduling and delivery of the full PSQ programme to meet project milestones.

You will define PQ requirements, author PQ protocols for manufacturing equipment, help develop PQ schedules and sequencing, and participate in site meetings to ensure timely handover of utilities and equipment to the