CQV Engineer

Quanta Consultancy Services Ltd; Roscommon; On-site; EUR 70,000 - 110,000; Full time

Job summary

Quanta Consultancy Services Ltd is seeking a CQV Engineer for a 12-month contract in Ireland within the Life Sciences sector. The role focuses on developing and owning CQV activities aligned with GMP and project schedules, including PQ readiness for critical equipment and systems.

The candidate will act as Client C&Q Lead, coordinating CQV interfaces and managing internal stakeholders across Quality, Manufacturing, and Engineering to ensure successful project delivery.

Qualifications

• Degree qualification in Engineering, Science, related discipline or relevant experience.
• Relevant experience in pharmaceutical and GMP regulated manufacturing environments.
• Extensive GMP experience, with demonstrable experience.
• Proven track record of commissioning and qualification involving solid dosage process equipment installation.
• Experience planning and delivering complex commissioning and qualification of systems.
• Excellent stakeholder management and reporting skills; able to present to senior leadership and governance forums.

Responsibilities

• Develop and own CQV activities aligned to GMP requirements up to PQ.
• Act as Client C&Q Lead coordinating CQV interfaces.
• Plan and lead system commissioning and qualification per schedule.
• Oversee commissioning partner and subcontractors.
• Coordinate commissioning of utility and facility systems.
• Interface with Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.

Skills

GMP experience

Stakeholder management

Commissioning & Qualification

Project coordination

Education

Engineering or Science degree

Job description

CQV Engineer – Ireland – Initial 12-Month Contract – Life Sciences

Our client, a global pharmaceutical company, are looking for a CQV Engineer to support the delivery their project based in Ireland.

The company has grown to become a world leader in the development, manufacture and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems.

What you’ll deliver:

• Develop and own the Commissioning, Qualification & Validation (CQV) activities associated with your project, aligned to project schedule and GMP requirements up to Performance Qualification of all systems and equipment.
• Act as Client C&Q Lead for the project. Throughout execution; coordinate all commissioning and qualification activities and act as single point of contact for CQV interfaces.
• Plan and lead execution of system commissioning and qualification of equipment in accordance with project schedule and phased release of areas.
• Oversee and coordinate Commissioning Partner and commissioning sub-contractors; manage performance against scope and programme.
• Commissioning partner responsible for commissioning of utility and facility systems.
• Interface with internal stakeholders including Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.

Experience required:

• Degree qualification in Engineering, Science, related discipline or relevant experience
• Relevant experience in pharmaceutical and GMP regulated manufacturing environments.
• Extensive GMP experience, with demonstrable experience.
• Proven track record of commissioning and qualification involving solid dosage process equipment installation.
• Experience planning and delivering complex commissioning and qualification of systems.
• Excellent stakeholder management and reporting skills; able to present to senior leadership and governance forums.