Process Engineer

Careerwise Recruitment; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

CareerWise Recruitment is seeking a Process Engineer (PQ) for a multinational biopharmaceutical client in Limerick on an initial 12-month, full-time onsite contract.

Role involves supporting early PQ strategy, BOM definition for PQ studies, consumables & sampling requirements, and authoring PQ strategies and protocols. Collaboration with cross-functional teams will be essential to ensure on-time site readiness.

Qualifications

• Must have Level 8 Engineering/Science Degree.
• Minimum 5 years in commissioning and qualification of pharma equipment/utilities, preferably during start-up.
• Proficient with MS Project
• Knowledge of GMPs, regulatory requirements, equipment commissioning and qualification.

Responsibilities

• Schedule and deliver the PSQ programme.
• Coordinate with Global Facilities delivery (GFD) Commissioning and Qualification Team for safe, on-time transfer of utilities & equipment.
• Maintain PSQ schedule with the PSQ PM.
• Define PQ study requirements and author PQ protocols for production equipment readiness.
• Contribute to PQ schedule development by defining equipment groups, logic and duration for PQ studies.
• Develop detailed BOMs for PQ studies including consumables and raw materials.

Skills

GMP knowledge

Regulatory requirements

Project coordination

Education

Level 8 Engineering/Science Degree

Tools

MS Project

Job description

A Process Engineer is required by CareerWise Recruitment for our multinational biopharmaceutical client in Limerick for an initial 12-month contract and full time onsite. The Process Engineer (Process Support Qualification) will join a cross functional team delivering the process start up for a greenfield site. They will provide engineering support required for early PQ strategy development activities, including bill of materials definition for PQ studies, consumables requirements, sampling requirements, authoring PQ strategies and protocols.

Role of this position

Support in scheduling & delivery of the PSQ Programme.

Co-ordination & interaction with the Global Facilities delivery (GFD) Commissioning and Qualification Team for safe, on-time transition of utilities & equipment to the site process team.

Maintaining PSQ Schedule with the PSQ PM.

Define PQ study requirements and author PQ protocols to prepare production equipment to support manufacturing activities.

Input to PQ schedule development - defining equipment groups, logic, and duration for required PQ studies.

Responsible, with input from relevant SMEs, for developing detailed bill of materials for PQ studies based on family groupings / bracketing approach, including consumables and raw materials components for PQ studies.

Job Requirements

• Level 8 Engineering/Science Degree (required).
• Minimum 5 years project experience in the commissioning and qualification of pharma equipment and utilities preferably during start-up activities.
• Proficient with MS Project
• Knowledge of GMP'S, regulatory requirements, equipment commissioning and qualification