CQV Engineer

  • Job Reference: 00039405-1
  • Date Posted: 17 February 2021
  • Recruiter: CV-Library
  • Location: United Kingdom
  • Salary: On Application
  • Sector: Healthcare & Medical, Science & Technology, Covid-19
  • Job Type: Contract

Job Description

CQV Engineer (Temperature Controlled Equipment)

The Vaccines Manufacturing and Innovation Centre (VMIC) has been established to provide the UK’s first strategic vaccine development and advanced manufacturing capability. VMIC will fast track development and manufacture of early-stage vaccine products, as well as serve as the UK’s response capability to produce vaccines against emerging infectious diseases. They have already taken a leading role in the Government’s national response to COVID-19.

New starters can expect to join an exciting fast-paced organisation, with ambitious growth plans. With a flat structure, employees will have exposure to senior leaders and be part of an organisation that has a start-up mentality but is backed by the UK Government, and industry and academic founders.

Working through collaborative ventures with industry, academia and NGOs, VMIC will ultimately strengthen and innovate the UK’s vaccines sector. Their state-of-the-art vaccines manufacturing facility will be located on the renowned Harwell Science and Innovation Campus near Didcot in Oxfordshire.

Adepto is working closely with VMIC UK Ltd to support the recruitment of a C&Q Engineer (TCU) with experience of qualifying temperature-controlled units including fridges, freezers, isolators, incubators, and autoclaves. The role involves working with the C&Q Manager & C&Q Lead to define and implement the C&Q strategy for production/laboratory equipment, facilities, and utilities on the VMIC Facility in Harwell Oxfordshire. This will be achieved through the preparation and execution of high-quality C&Q documentation.

Responsibilities:

* Assist C&Q Lead in preparation/update of C&Q standard operating procedures.

* Participate as C&Q SME to the URS preparation process.

* Review and approve supplier factory acceptance tests and site acceptance test plans/protocols for Temperature Control Unit (TCU) systems.

* Witness the execution of factory acceptance tests (FAT) and site acceptance test (SAT) plans/protocols for TCU systems.

* Prepare risk assessments, traceability matrix and C&Q protocols (DQ/IQ/OQ/PQ) for TCU systems.

* Co-ordinate review and approval of risk assessments, design specification and functional specification, traceability matrix and C&Q protocols (DQ/IQ/OQ/PQ) for TCU systems.

* Execute C&Q protocols (DQ/IQ/OQ/PQ) and prepare C&Q summary reports.

* Assist C&Q Lead in maintaining the qualification status of production/laboratory equipment, facilities, and utilities systems according to a predefined frequency and in accordance with current internal SOPs.

* Contribute to ensure that changes introduced in the organization of quality systems, procedures and processes are managed so that all aspects of the equipment, facilities and utilities systems commissioning, and qualification process are assessed and accordingly performed.

We are seeking proactive, flexible, highly motivated, and quality professionals to support C&Q projects within a fast moving and cutting-edge organisation. Candidates will be degree qualified with substantial C&Q experience preferably with biologics and sterile manufacturing. Knowledge of the necessary qualification and validation steps and tools (FMEA, RA, URS, DQ, IQ, OQ, PQ) and detailed knowledge of GMP requirements and their technical implementation in clean room classes A to D is essential.

Equal Opportunities

VMIC is proud to be an equal opportunity employer. We welcome applications from all individuals regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any other protected characteristic. We are committed to treating all applicants fairly and without discrimination