CQV Process Equipment Engineer

QCS Staffing; Roscommon; On-site; EUR 80,000 - 110,000; Full time

Job summary

CQV Process Equipment Engineer role based in Roscommon, Ireland, on an initial 12-month contract within the life sciences sector. You will develop and own CQV activities, ensuring alignment with GMP requirements and project schedules, up to performance qualification of all systems and equipment.

As Client C&Q Lead, you will coordinate commissioning and qualification activities, interface with Quality, Manufacturing, and Engineering teams, and manage commissioning partners and subcontractors to

Qualifications

• Degree qualification in Engineering, Science, related discipline or relevant experience.
• 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.

Responsibilities

• Develop and own the Commissioning, Qualification & Validation (CQV) activities aligned to project schedule and GMP requirements up to Performance Qualification.
• Act as Client C&Q Lead for the project and coordinate CQV interfaces and activities.
• Oversee and coordinate commissioning partners and sub-contractors; manage performance against scope and programme.

Skills

CQV processes

GMP experience

Project coordination

Education

Degree in Engineering or Science

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.