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CSV Engineer - 3 Month Contract

Employer
Hyper Recruitment Solutions
Location
Cheshire
Salary
£50 - £60 per hour
Closing date
30 Apr 2021

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Contract Type
Contract
Hours
Full Time

Job Details

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

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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