CSV Engineer - 3 Month Contract

Location
Cheshire
Salary
£50 - £60 per hour
Posted
31 Mar 2021
Closes
30 Apr 2021
Ref
J5634713
Contact
Marcus Rossi
Contract Type
Contract
Hours
Full Time
Are you an experienced CSV Engineer looking for a new job opportunity?

We are currently looking for a CSV Engineer to join a growing pharmaceutical company based in the
Runcorn Area on a 3-6 month contract.

As the CSV Engineer you will be responsible for overseeing all aspects of the computer system validation programme and be responsible for authoring, executing and reporting technical validation activities within GMP framework.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the CSV Engineer will be varied however the key duties and responsibilities are as follows:

1. You will be 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 and ensuring the validation status of computer systems are compliant with cGMP.

2. You will manage validation documentation, commissioning test scripts, validation protocols, summary reports and risk assessments as well as report validation documentation to meet regulatory and company requirements including Validation Plans, User Requirement Specifications, Design Specifications and SOPs. This will also include author, review and execution of Qualification Documents (DQ, IQ, OQ, PQ).

3. Additionally, you will be responsible for maintaining accurate validation documentation through the validation lifecycle and audit as CSV subject matter experience. You will represent CSV at internal and external audits and follow up on actions arising.

4. You will provide project teams with expert computerised system validation guidance and definition of appropriate CSV strategies and also train other staff members on the correct use of computerised systems in line with protocols and regulations.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the CSV Engineer we are looking to identify the following on your profile and past history:

1. Relevant Degree in Life Science, Engineering or Computer Science and proven industry experience in computer systems within the pharmaceutical industry is essential for this role.

2. 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 is also required.

3. Additionally, as the CSV Engineer, you will also need to have had experience managing and documenting validation processes.


Key Words: Computer Systems | CSV | Engineer | Validation | Computer Science | Pharmaceutical | Biopharmaceutical | GMP | Life Science

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