C&Q Engineer: GMP Validation & CAPEX

Tandem Project Management Ltd.; Waterford; On-site; EUR 55,000 - 85,000; Full time

Job summary

Tandem Project Management Ltd. seeks an experienced C&Q Engineer for a biopharmaceutical client in Waterford. You will support commissioning, qualification and validation across manufacturing systems, utilities, and laboratory equipment within GMP-regulated environments.

The role covers CAPEX project support, ensuring systems are qualified and maintained per regulatory and quality requirements. Strong cross-functional collaboration is essential.

Qualifications

• Degree or equivalent in Engineering, Life Sciences or related technical discipline.
• Experience in a C&Q, Validation or Engineering role in pharma or regulated manufacturing.
• Experience supporting laboratory systems qualification.
• Experience with clean utilities commissioning and qualification (PW, WFI, Clean Steam, Process Gases).
• Experience on CAPEX projects within GMP-regulated environments.
• Strong GMP knowledge and qualification lifecycle understanding.
• Experience supporting qualification for manufacturing equipment, utilities, or facilities.
• Excellent communication and cross-functional teamwork across project teams.

Responsibilities

• Support commissioning and qualification activities across manufacturing equipment, utilities, labs and facilities.
• Execute IQ/OQ/PQ protocols and associated reports, including deviation management.
• Assist CAPEX-related qualification and validation from design through completion.
• Collaborate with Engineering, Manufacturing, Quality and Validation teams to ensure compliance.
• Participate in FATs/SATs, walkdowns and system turnover activities as required.
• Support investigations, deviations, change controls and CAPA actions tied to qualification work.
• Ensure activities meet GMP requirements and internal procedures.

Skills

C&Q experience

Validation experience

Cross-functional collaboration

Effective communication

Education

Engineering or Life Sciences degree

Job description

Tandem Project Management Ltd. seeks an experienced C&Q Engineer for a biopharmaceutical client in Waterford. You will support commissioning, qualification and validation across manufacturing systems, utilities, and laboratory equipment within GMP-regulated environments.

The role covers CAPEX project support, ensuring systems are qualified and maintained per regulatory and quality requirements. Strong cross-functional collaboration is essential.