C&Q Engineer - must have valid EU Work Permit

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C&Q Engineer - must have valid EU Work Permit, Cork

Client: PACIV

Location: Cork, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference:

8630184a3b09

Job Views:

2

Posted:

24.04.2025

Expiry Date:

08.06.2025

Job Description:

PACIV, a global leader in industrial automation solutions with offices in Ireland, the United States and Puerto Rico, and serving the Life Science, F&B and Utilities industries, is looking for an experienced Commissioning & Qualification (C&Q) Engineer.

This is a site-based role working within a multinational life science manufacturing environment in Cork, Ireland. Strong field experience working with a range of black and clean utilities is required for this role.

Responsibilities of the Role:

• Development and execution of C&Q deliverables for black and field utilities for an expansion project at a life science manufacturing company.
• Support and coordinate the quality process over the life cycle of the projects assigned with specific focus on C&Q.
• Preparation of Qualification Plan, Impact Assessment, Criticality & GMP Risk Assessments, User Requirements, Design Qualification (DQ), Traceability Matrix, Commissioning (FAT/SAT), Testing (IQ/OQ/PQ), Quality Report, and Master Document List.
• Detailed understanding and experience with current regulations for C&Q such as FDA cGMP’s for Risk-Based Approach and ISPE C&Q Guidelines.
• Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to C&Q and project requirements.

Requirements:

• Minimum of 5 years’ strong field experience working with a range of black and clean utilities.
• Minimum of 5 years’ experience in a similar role in life sciences, ideally in Pharmaceutical manufacturing.
• Fluent in English, written and verbal.
• Education: Bachelor’s degree in engineering (Mechanical or related engineering/science studies).
• Knowledge and experience of utilities processes and technologies.
• Experience in development and execution of C&Q deliverables for system-development life cycle.
• Experience with development and execution of DQ, Validation and Test Planning, Development and Execution (C&Q/CSV, IQ/OQ/PQ, Loop Checks, collate results and prepare Final Reports).
• Works well with others, within a team and takes accountability.
• Result driven and self-motivated.
• Strong interpersonal and communication skills (verbal and presentation).
• Organised, with strong computer literacy.
• Must have valid EU Work permit and Irish Residency.

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