Senior CSV Engineer - Gene Therapy - London

London, England
£50000 - £65000 per annum + 10% bonus, life assurance, healthare
16 Sep 2019
30 Sep 2019
Dominic Williams
Full Time
Contract Type
Experience Level
Experienced (non-manager)


i-Pharm Consulting are delighted to be working exclusively with the most innovative tech-focussed ATMP service provider within the UK Biotechnology market. This is a truly unique organisation founded by industry experts who have successfully created a success culture at the cutting edge of the cell and gene therapy space. They are now looking to strengthen their cohesive team with a forward-thinking CSV engineer who wants to apply their experience at the very forefront of the Immuno-oncology sector.


- Senior CSV Engineer


- Revolutionary ATMP organisation
- Using innovative blockchain technology within the Cell/Gene Therapy space
- Opportunity to lead technical/corporate projects as business SME
- Unique opportunity to network with industry leaders
- Excellent benefits package and role flexibility


- London, UK


- Performing CSV and related IT tasks as the business SME in line with industry GMP standards
- Conducting computerised validation activities to ensure compliance of full GxP system and ERP
- Involvement with various departments departments for operational validation scopes (e.g. GAMP)
- Input to all stages of the validation lifecycle (IQ/OQ/PQ) requirements in support of smooth operation and business growth
- Deputise for the Validation Manager as and when required
- Active collaboration with management for continual quality performance improvement for the overall function


- 5+ years' experience within pharmaceutical/biotech GMP validation role
- Demonstration of CSV compliance (GAMP5 regulations, Annex 11 and CFR Part 11)
- Evidence of leading CSV projects across the full validation IQ/OQ/PQ lifecycle
- Effective communication skills
- Ability to work alone or as part of a team

- Knowledge and/or experience of working with blockchain technology is highly desirable

- Sound understanding of laboratory processes

About i-Pharm Consulting

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Validation and Bioinformatics.


If you would like to discuss this vacancy further, please call Team Leader Dominic Williams on +44 (0)20 3873 7066, or email If this role is not suitable, Dominic is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


CAPA / QMS / Audit / Auditor / GxP / GCP / GMP / GLP / GDP / GDPR / SOP / Cleaning / Validation / CSV / Equipment / Manufacture / Manufacturing / Facility / Utilities / Machinery / HVAC / CFR / Annex II / Annex 15 / Gene Therapy / Cell Therapy / ATMP / Advanced Therapies / Car-T / CAR T / T Cell / B Cell / Medical Device / Sterile / Biologics / Microbiology / Microbiologist / IQ / OQ / PQ / cGMP / CSV / CFR / Blockchain / Automation / AI / Data Governance / IT / Computer Systems / Author / SOP writing / SOP / SAE / Quality Assurance / QA / QA specialist / Compliance / V-Model / Manager / Leader / QC / Quality Assurance / Quality Control / Senior Manager / Senior Management / Pharmaceutical / Quality Engineer / QA Engineer / Validation Engineer / Biotechnology / NCR / CAPA / London / Middlesex / Hertfordshire / Westminster / Buckinghamshire / Oxfordshire / Surrey / Essex

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