CQV Engineer

QCS Staffing; Roscommon; On-site; EUR 65,000 - 90,000; Full time

Job summary

CQV Engineer – Ireland – Initial 12‑Month Contract – Life Sciences is sought to support commissioning, qualification and validation activities within GMP environments in Ireland. The role requires delivering CQV for systems up to Performance Qualification, acting as the Client C&Q Lead and coordinating interfaces across Quality, Manufacturing and Engineering.

Candidates should hold an Engineering or Science degree with extensive GMP experience in pharmaceutical manufacturing and a proven track

Qualifications

• Degree qualification in Engineering or Science
• Extensive GMP experience in pharmaceutical environments
• Experience commissioning and qualification of solid dosage equipment
• Ability to plan and deliver complex CQV activities
• Excellent stakeholder management and governance reporting skills

Responsibilities

• Develop and own CQV activities aligned to GMP requirements
• Act as Client C&Q Lead coordinating CQV interfaces
• Plan and lead system commissioning and qualification to project schedule
• Oversee commissioning partners and subcontractors against scope
• Interface with Quality, Manufacturing, Operations and EHS stakeholders

Skills

Stakeholder management

Executive reporting

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.