Senior CQV Engineer – API Process, Tipperary (Contract)

Dillon Engineering Services; Munster; On-site; EUR 110,000 - 138,000; Full time

Job summary

Dillon Engineering Services is seeking a Senior Process C&Q Engineer / CQV API Project Lead on a contract basis to support a major pharma API manufacturing project in Tipperary.

The role involves commissioning and qualification of API process equipment and utilities, with hands-on C&Q delivery from construction handover through start-up and final handover, ensuring GMP/GEP compliance and safe operation across the project lifecycle.

Qualifications

• Degree in Engineering or Science or equivalent.
• 10+ years in commissioning & qualification (C&Q/CQV) within pharma/biotech/API environments.
• Hands-on C&Q experience on large-scale pharma projects.
• Strong knowledge of API process equipment and utilities.
• Experience preparing IOC/IOQ and installation verification docs.

Responsibilities

• Prepare, review and execute commissioning and qualification documentation for API process equipment and systems.
• Develop and execute electronic commissioning and qualification protocols, including IOC and IOQ.
• Perform field walkdowns, installation verification and system inspections to support construction handover.
• Coordinate and support system start-up, functional testing, commissioning and qualification activities.
• Ensure the safe operation of equipment and systems throughout commissioning, start-up and qualification phases.
• Support C&Q activities for API process equipment, including filtration, drying and associated process systems.
• Manage change control activities throughout the project lifecycle.
• Prepare C&Q summary reports and associated technical documentation.
• Plan, organise and track daily commissioning and qualification activities to ensure project milestones are achieved.
• Coordinate contractors, equipment vendors and other technical personnel.
• Troubleshoot technical issues arising during commissioning and qualification.
• Liaise with Construction, Engineering, Automation, Quality, Validation and End User teams throughout the project lifecycle.
• Ensure all activities comply with GMP, Good Engineering Practice (GEP), site procedures and relevant safety requirements.
• Provide technical guidance and support to other C&Q personnel as required.

Skills

C&Q experience

GMP/GEP knowledge

Project coordination

Documentation & report writing

Communication skills

Education

Engineering/Science degree or equivalent

Tools

Electronic C&Q documentation systems

Job description

Dillon Engineering Services is seeking a Senior Process C&Q Engineer / CQV API Project Lead on a contract basis to support a major pharma API manufacturing project in Tipperary.

The role involves commissioning and qualification of API process equipment and utilities, with hands-on C&Q delivery from construction handover through start-up and final handover, ensuring GMP/GEP compliance and safe operation across the project lifecycle.