C&Q Engineer

NRL; Munster; On-site; EUR 70,000 - 100,000; Full time

Job summary

NRL is seeking a capable C&Q Engineer to lead commissioning and qualification activities on major pharma/biotech projects in Ireland. You will prepare lifecycle docs (IV, FT, IQ, OQ), run FAT, SAT, and design qualification protocols, and coordinate with Construction, Automation, Quality and Operations teams.

You will ensure safe startup, perform system verifications, and drive change management across the project lifecycle.

Qualifications

• Hands-on experience with C&Q activities on pharma/biotech projects.
• Strong communication skills, verbal and written.
• Ability to work independently and within a team.
• Familiarity with GMP/GEP regulatory standards.

Responsibilities

• Execute commissioning and qualification activities per project plans.
• Prepare lifecycle documentation (IV, FT, IQ, OQ).
• Prepare and execute FAT, Commissioning, SAT protocols.
• Prepare, execute, and close qualification protocols (IQ/OQ).
• Coordinate with Construction, Engineering, Automation, Quality and End Users.
• Ensure safe operation during startup and testing phases.

Skills

Hands-on C&Q

Communication skills

Independent worker

Team player

Education

Degree in Science or Engineering

Certificate or diploma in related discipline

Job description

The C&Q Engineer is responsible for the execution of project-related commissioning and qualification activities, including but not limited to the following:

• Preparation of lifecycle documentation in support of C&Q activities, including IV, FT, IQ, and OQ.
• Preparation and execution of Factory Acceptance Testing (FAT), Commissioning, and Site Acceptance Testing (SAT) protocols.
• Preparation, execution, and completion of qualification protocols (IQ and OQ).
• Preparation, execution, and follow-up of Design Review (DR) and Design Qualification (DQ) activities.
• Conducting system field walkdowns as part of the transfer of ownership from Construction to Operations.
• Ensuring safe operation of systems prior to and during start-up, functional testing, and qualification phases.
• Execution of Installation Verification activities.
• Support and execution of system start-up activities.
• Functional testing of systems in accordance with approved protocols.
• Participation in change management activities throughout the project lifecycle.
• Preparation of summary reports and final documentation packages.
• Planning, organising, and reviewing daily tasks and verifications, and tracking progress of assigned activities.
• Coordination with contractors and vendors.
• Interfacing with project stakeholders including Construction, Engineering, Automation, Quality, and End Users across all project phases.
• Degree in Science or Engineering, or equivalent.

OR

• Certificate or diploma in a related discipline with relevant industrial experience.
• Minimum of 5 years’ experience performing C&Q activities on large-scale pharmaceutical or biotech projects.

Hands-on experience in one or more of the following areas:

• Black and Clean Utilities
• Purification Equipment
• Reactors
• Filtration Equipment
• CIP Systems
• Upstream and/or Downstream Process Equipment
• Strong understanding of GMP and GEP regulatory and industry standards.
• Self-motivated with the ability to work independently and as part of a team.
• Strong oral and written communication skills.