Process Engineer

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