Senior Process C&Q Engineer

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

Title: Senior Process C&Q Engineer

Location: Tipperary, Ireland

Contract Type: Contract

Hourly Rate: €80–€100 per hour (depending on experience)

Work Arrangement: Site-based, 5 days per week

Industry: Pharmaceutical / API Manufacturing

Job Overview

Dillon Engineering Services is currently seeking an experienced Senior Process C&Q Engineer / CQV API Project Lead for a contract opportunity supporting a major pharmaceutical API manufacturing project in Tipperary.

The successful candidate will be responsible for the commissioning and qualification of API process equipment and associated utility systems, supporting activities from construction handover through system start-up, qualification and final handover.

This is a hands-on technical role requiring extensive C&Q experience within pharmaceutical or API manufacturing environments. Previous experience with Filter Dryers and/or pharmaceutical utilities would be a distinct advantage.

Key Responsibilities

• Prepare, review and execute commissioning and qualification documentation for API process equipment and associated utility 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.

Qualifications & Experience

Essential Requirements

• Degree in Engineering, Science or a related discipline, or equivalent technical qualification supported by relevant industry experience.
• Minimum of 10 years' experience in Commissioning & Qualification (C&Q/CQV) within pharmaceutical, biotechnology or API manufacturing environments.
• Proven hands‑on C&Q experience on large‑scale pharmaceutical projects.
• Strong technical knowledge of API process equipment, pharmaceutical utilities and/or facilities systems.
• Experience preparing and executing commissioning and qualification protocols, including IOC, IOQ and installation verification.
• Experience with equipment walkdowns, system start‑up, functional testing and construction handover.
• Good understanding of GMP, GEP and relevant pharmaceutical regulatory requirements.
• Strong troubleshooting, technical documentation and problem‑solving skills.
• Ability to work independently, manage assigned activities and coordinate effectively with multidisciplinary project teams.
• Excellent communication, organisational and interpersonal skills.

Desirable Experience

• Hands‑on commissioning and qualification experience with Filter Dryers, particularly Agitated Nutsche Filter Dryers (ANFDs).
• Experience with API manufacturing equipment, including reactors, centrifuges, filtration systems, dryers and process vessels.
• Experience commissioning and qualifying pharmaceutical clean and/or black utility systems.
• Familiarity with electronic C&Q documentation and execution systems.
• Previous experience in a Senior C&Q Engineer or technical lead capacity.

Note: Only candidates who are legally authorised to work in Ireland will be considered for this role.