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CQV Engineer

Job title: CQV Engineer
Contract Type: Contract
Location: Manchester
Industry:
Salary: £60 - £65 per hour
Reference: BH-95602
Contact Name: Ellie Charlwood
Phone Number: +441619424011
Job Published: 24 days ago

Job Description

My client, a Pharmaceutical Manufacturer in the North West, is looking for an experienced CQV Engineer to join them on a contract basis

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

Please apply for more information

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