CQV Process Equipment Engineer

QCS Staffing; Roscommon; On-site; EUR 60,000 - 90,000; Full time

Job summary

QCS Staffing seeks a CQV Process Equipment Engineer for Roscommon, Ireland on a 12-month initial contract in the life sciences sector. The role focuses on commissioning, qualification, and validation of process equipment, acting as the CQV lead and coordinating interfaces with QA, Manufacturing, and Engineering teams.

The ideal candidate has a degree in Engineering or Science and extensive GMP experience, with a proven track record in solid dosage equipment commissioning and qualification.

Qualifications

• Degree in Engineering or Science or related field.
• Extensive GMP experience in pharmaceutical manufacturing.
• Experience commissioning and qualifying solid dosage equipment.

Responsibilities

• Own CQV activities aligned to project schedule and GMP requirements.
• Plan and lead system commissioning and qualification with phased release.
• Coordinate commissioning partners and subcontractors to meet scope and programme.
• Interface with Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.

Skills

CQV

Commissioning

Qualification

Project leadership

Education

Engineering or Science degree

Job description

CQV Process Equipment (OSD) Engineer – Roscommon, Ireland – Initial 12-Month Contract – Life Sciences

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