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CQV Specialist

Job title: CQV Specialist
Contract Type: Contract
Location: Manchester, England
Industry:
Salary: £45 - £50 per hour
Reference: BH-94234
Contact Name: Daniel Leach
Phone Number: 01
Job Published: 3 days ago

Job Description

My client is a Biopharmaceutical company based in the North West. Due to an expansion project they are looking for an experienced CQV Specialist to join their team. 

Job Role & Responsibilities 

Proposed Responsibilities   Primary Function:

  • To provide CQV expertise to project teams in the office or on sites
  • To provide CQV expertise on our client’s sites when such requests arise (i.e. secondment type work)
Main Duties and Responsibilities:

  • Assist in the production of Commissioning Qualification or Validation Master Plans, (under the supervision of the regulatory compliance specialist)
  • Prepare and execute Risk Assessment protocols (System and Component Impact Assessment)
  • Prepare and execute Design Qualification protocols
  • Prepare and execute Installation Qualification protocols
  • Prepare and execute Operational Qualification protocols
  • Initiate and maintain a cGMP change control system during the validation programme
  • Review design documentation to ensure CQV and general cGMP requirements are being provided for (under the supervision of the regulatory compliance specialist)
  • Review design documentation to ensure CQV and general cGMP requirements are being provided
  • Participate in project Start-up activities including preparation and execution of Installation Verification and Operational verification documents (Commissioning)
  • Liaison with construction and relevant contractors for effective system handover both mechanical and E&I.
  • Knowledge of DeltaV or similar control system (preferred, but not essential)
  • Prepare and execute IQ and OQ protocols
  • Initiate and maintain a cGMP change control system during the C&Q lifecycle
Qualifications and Comments: 

  • Educational Professional Qualifications Required   Key Competencies: (Education, Training, Skills, Experience)
  • CQV Engineer: A degree in chemical, mechanical, or electrical engineering or equivalent
  • CQV Specialist: A degree in Chemistry, Microbiology, Physics, Biochemistry or equivalent
Or

  • A certificate/diploma in similar areas with appropriate industrial experience
  • Experience of Commissioning Qualification and Validation in the biopharmaceutical industry. (5-10 yrs)
Additional Competencies: (Education, Training, Skills, Experience)

In order of priority:

  • Experience of Commissioning Qualification and Validation in similar engineering company and project environment.
  • Experience of Commissioning Qualification and Validation in the general pharmaceutical industry. (3-5 yrs)
  • Experience with Regulatory and industry standards for GMP and GEP
  • Experience using the ISPE baseline guides
  • Self-starter
  • Good team player
  • Good oral and written communication skills
For more information please contact -

Daniel Leach

+44 161 942 7137

daniel.l.a2tui26s1@nesgt.aptrack.co.uk 

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