Greater Manchester, United Kingdom
27 days ago
We are looking to recruit a Commissioning, Qualification and Validation (CQV) Engineer to join our client based in Greater Manchester on a long-term contract basis. Our client is a leading multidiscipline engineering consultancy who work across a number of sectors including Pharmaceutical, Healthcare, Fine Chemical and Life Sciences.
What’s the job?
The main purpose of the role is to provide CQV input in the preparation of deliverables throughout the entire project life -cycle. Ensuring compliance with the CQV strategy.
Other duties include;
- Work with clients and the project team to define CQV requirements
- Prepare, execute and review GMP documentation:
- Validation Master Plan
- Risk Assessment protocols (System and Component Impact Assessment)
- User Requirement Specifications (equipment and facility)
- Design Qualification (DQ), including preparation of RTMs
- Qualification documentation (IQ, OQ & PQ)
- Commissioning plan
- Factory Acceptance Test (FAT) and Site Acceptance Test ( SAT)
- 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.
What experience and qualifications do you need?
- 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
- Experience of validation of Secondary Pharmaceutical facilities
- Experience of validation of Biotechnology facilities
- Experience of validation of Single Use Technologies
- Deep understanding of and ability to apply GMP, GAMP and CFR21 Part 11 guidelines.
- Experience in qualification activities for pharmaceutical and biotechnology facilities
- Deep understanding of and ability to apply GMP, GAMP and CFR21 Part 11 guidelines
- Experienced with specification and validation in the following areas: equipment qualification (including autoclaves & parts washer), manufacturing and utility systems (WFI, Clean Steam, CIP & SIP)
- Familiar with GxP, ISPE and/or ASTM E2500
- Ability to work as part of a team, liaising directly with client and other project team members
- Problem solving and originality
- Computer literate, in particular MS Office programmes
- Ability to work under pressure and with minimum supervision
£50 - £65 Ltd per hour
If you feel this opportunity could be a fit for your skills and experience, please click the apply button.
During the COVID19 situation our clients are still working and recruiting. The interview process will consist of video interview and then face to face interviews while respecting the social distancing rules.
Recruitment processes with our Clients usually move quickly and successful applicants will advance to interview stage promptly. Regrettably, only applicants who demonstrate the required experience outlined in the advert will be contacted.