Marketplace Technical

CSV Engineer

England, Runcorn, Cheshire
19 Jun 2021
29 Jun 2021
Andrew Williams
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced CSV Engineer to

oversee all aspects of the computer system validation programme. Responsible for

authoring, executing and reporting technical validation activities within GMP framework.

Duties may include:

* Ensure the validation status of computerised systems are compliant with cGMPs

* Responsible for the implementation of a risk-based approach to the validation of Computerised systems in accordance with EU GMP Annex 11, 15 and GAMP 5, whilst ensuring compliance with the company QMS

* Manage validation documentation, commissioning test scripts, validation protocols, summary reports and risk assessments

* Author and report validation documentation to meet regulatory and company requirements including Validation Plans, User Requirement Specifications, Design Specifications and SOPs

* Author, review and execute Qualification Documents (DQ, IQ, OQ, PQ)

* Maintain accurate validation documentation through the validation lifecycle

* Troubleshoot in the event of abnormal testing results

* Audit as CSV subject matter expert

* Represent CSV at internal and external audits and follow-up on actions arising

* Provide project teams with expert computerised system validation guidance and definition of appropriate CSV strategies

* Work closely with all functions and particularly project leaders, Engineering, IT, QC and Quality

* Train other staff members on the correct use of computerized systems in line with protocols and regulations

* Keep up to date with advances in the field and regulatory requirements

* Recommendation of process upgrades and improvements in efficiency

* Ensure projects are managed in conjunction with all regulatory requirements such as health & safety and cGMP

* Ensure compliance with environment, health and safety rules, signage and instructions

* Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

Skills and experience:

* BSA or MS degree in life science / engineering / computer science

* Proven industry experience in Computer systems within the pharmaceutical industry

* Good knowledge of GAMP5 guide and MHRA GxP Data Integrity Guidance and Definitions, FDA 21 CFR Part 11, EMA Annex 11 regulations

* Broad knowledge of the commissioning and qualification of computerised systems within a GMP regulated environment

* Strong documentation bias. Experience managing and documenting validation processes

* Attention to detail. Ability to quickly identify when something isn't correct and take effective action

* Good written communication skills and a structured approach to working

* Good communication skills. Ability to work with people from across the business