Jacobs Junior Commissioning, Qualification and Validation (CQV) Engineer / Specialist in Stockport, United Kingdom

Junior Commissioning, Qualification and Validation (CQV) Engineer / Specialist

Description

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.

  • Prepare and execute IQ and OQ protocols

  • Initiate and maintain a cGMP change control system during the C&Q lifecycle

Qualifications

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. (1-5 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. (1-3 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

Primary Location United Kingdom-United Kingdom Countrywide-Stockport

Req ID: LIF0000AQ