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DATE ADDED: Thu 01/11/2018

Commissioning, Qualification And Validation Engineer

Manchester, UK
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JOB TYPE: Contract

Commissioning, Qualification and Validation Engineer/ Specialist Primary Function: • To provide CQV expertise to project teams in the office or on sites • To provide CQV expertise on our clientrsquos 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 EI. 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 CQ lifecycle Qualifications Educational Professional Qualifications Required 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 bio-pharmaceutical 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
Role: Commissioning, Qualification and Validation Engineer
Job Type: Contract
Location: Manchester, Greater Manchester,

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