Computer System Validation Engineer - Lab Systems

Job type:
Start date:
Quanta Consultancy Services
Published at:
flag_no United Kingdom
Contact person:
Lee Mitchell
Project ID:

This project has been archived and is not accepting more applications.
Browse open projects on our job board.
Pharmaceutical manufacturing plant in India have a long term urgent contract requirement for an experienced CSV Engineer with Lab Instruments and software experience to work on a large scale remediation programme.  This is to get the site moving towards manufacturing, GMP  and FDA readiness.

 Experience required


- Experience in Computer Systems Validation in an FDA regulated environment is preferred

- Experience in Infrastructure Qualification

- Knowledge of 21 CFR Part 11

- Knowledge and experience working with GAMP5 guidelines for computer systems validation

- Past experience in writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ,PQ, Risk Assessments, Requirement Specifications, RTM, Summary Reports)

- Experience in validating one or more of the following types of systems is desirable: Chromeleon Chromatography Data Systems, UV Probe, TOC, Analytical Lab Instrument Software

- Bachelor’s degree preferred in Computer Science/IT, Engineering or related discipline and 5+ years’ experience in a computer systems validation role

- Excellent communication skills

- Proficiency with MS Office Tools

- Documentation Management

- Strong Project Management experience, preferred but not required

- CSV Lab Instruments ill include:Lab X, RFM, Millitrack, HMI, UV Probe, Chromeleon. Good Laboratory systems will be essential  !

Flights, accommodation, per dieme, food included together with the hourly rate. For further information on this project call me on