Process Engineer

CareerWise Recruitment; Limerick; Presencial; EUR 65.000 - 80.000; Jornada completa

Descripción de la vacante

CareerWise Recruitment is seeking a Process Engineer (Process Support Qualification) in Limerick for a 12-month, full-time onsite role with a multinational biopharmaceutical client.

The engineer will join a cross-functional team to deliver process startup for a greenfield site, developing PQ strategies and protocols, defining BOMs and consumables, and supporting early PQ activities.

Formación

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

Responsabilidades

• Support in scheduling and delivery of the PSQ Programme.
• Coordinate with Global Facilities delivery (GFD) for safe, on-time transition of utilities and equipment.
• Maintain PSQ Schedule with the PSQ PM.
• Define PQ study requirements and author PQ protocols.
• Input to PQ schedule development – equipment groups, logic, and duration.
• Develop detailed BOMs for PQ studies including consumables and materials.

Conocimientos

GMP knowledge

Project coordination

Educación

Level 8 Engineering/Science Degree

Herramientas

MS Project

Descripción del empleo

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.

THE ROLE:

• 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.

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

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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