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Date Added: Wed 04/11/2020

CQV Engineer

Manchester, UK
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Job Type: Contract

Salary: £50 - £60 / hourly

Position: CQV Engineer

Location: Manchester OR London

Type: Contract

Duration: Long Term

First Recruitment Group are currently recruiting for a Commissioning Qualification Validation Engineer to provide CQV input in the preparation of deliverables throughout the entire project life cycle, from the engineering phase until the Commissioning and Qualification execution on site.

In-depth understanding of GMPs and pharmaceutical and biopharmaceutical unit operations essential

Responsibilities & Accountabilities

•             Work with clients and the project team to define CQV requirements

•             Prepare, execute and review GMP documentation:

o             Validation Master Plan

o             Risk Assessment protocols (System and Component Impact Assessment)

o             User Requirement Specifications (equipment and facility)

o             Design Qualification (DQ), including preparation of RTMs

o             Qualification documentation (IQ, OQ & PQ)

o             Commissioning plan

o             Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)

o             Final report

•             Review design documentation, generated by all disciplines to ensure CQV and general cGMP requirements are being provided for

•             Review equipment specifications to ensure GMP compliance

•             Review engineering deliverables for accuracy and compliance

•             Participation and lead GMP Reviews and Risk Assessments (FMEA)

•             Carry out audits to demonstrate the design complies with project GMP requirements

•             To ensure quality issues are fully considered in a project

•             Undertake any other reasonable tasks that are requested.

Essential Experience:

•             Degree or equivalent in an engineering related discipline,

•             Experience of generating CQV documentation, execution of commissioning / qualification protocols in pharmaceutical environment

•             Experience using the ISPE baseline guides

Desirable Experience:

•             Experience of validation of Secondary Pharmaceutical facilities

•             Experience of validation of Biotechnology facilities


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