Senior CSV Engineer - Gene Therapy - London

INTRODUCTION

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.

TITLE

- Senior CSV Engineer

JOB SUMMARY

- 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


LOCATION

- London, UK


RESPONSIBILITIES

- 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

REQUIREMENTS

- 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.
www.i-pharmconsulting.com


TO APPLY

If you would like to discuss this vacancy further, please call Team Leader Dominic Williams on +44 (0)20 3873 7066, or email dwilliams@i-pharmconsulting.com. 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.

KEY WORDS

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