09/21/2026 updated
100 % available
Senior CSV Validation Consultant
Warrington, United Kingdom
Only remote
BSc Honours Medical Microbiology, Manchester Metropolitan UniversityProject Management
CSV and CQV Lifecycle Management
Extensive expertise in leading risk-based CSV and CQV activities across pharmaceutical, biotechnology, cell and gene therapy, laboratory and GMP manufacturing environments throughout the full system lifecycle, including validation plans, risk assessments, IQ/OQ/PQ protocols, test scripts and reports.
GAMP 5 and Regulatory Compliance
Strong working knowledge of GAMP 5, EU GMP Annex 11, Annex 15, 21 CFR Part 11 and data-integrity requirements, with SME-level support provided across multiple client sites and project environments.
PLC, HMI and Automated Manufacturing Systems Validation
Hands-on experience providing CSV and CQV oversight for PLC, HMI and automated control functionality, including requirements, risk assessments, supplier documentation and qualification evidence for critical utilities, filling lines and automated manufacturing systems.
Audit Trails and User-Access Controls
Practical experience implementing and reviewing audit trails, system security and user-access controls in line with 21 CFR Part 11 and Annex 11 requirements.
FAT/SAT and Commissioning
Active participation in FAT, SAT, commissioning and qualification activities with equipment vendors and cross-functional Engineering, Automation, IT, Quality and Operations teams.
Data Integrity and Remediation
Conducting data-integrity assessments, supporting GMP system implementation, remediation and audit readiness, including cloud-based and bespoke computerized systems.
Deviations, CAPA and Change Control
Managing validation deviations, investigating non-conformances, supporting CAPAs and change controls through closure across multiple concurrent workstreams.
Temperature Mapping and Controlled-Environment Qualification
Performing temperature mapping and qualification of controlled-temperature equipment including refrigerators, freezers, cleanrooms and controlled environments.
Laboratory System Qualification
Qualifying HPLC, IcIEF, CGE, UPLC, endotoxin and particle sizer laboratory systems, integrating equipment into platforms such as Empower 3 and executing CSV and data-integrity documentation.
ValGenesis and HP ALM
Executing OQ scripts in ValGenesis and developing and executing OQ scripts using HP ALM for laboratory relocation and qualification projects.
Extensive expertise in leading risk-based CSV and CQV activities across pharmaceutical, biotechnology, cell and gene therapy, laboratory and GMP manufacturing environments throughout the full system lifecycle, including validation plans, risk assessments, IQ/OQ/PQ protocols, test scripts and reports.
GAMP 5 and Regulatory Compliance
Strong working knowledge of GAMP 5, EU GMP Annex 11, Annex 15, 21 CFR Part 11 and data-integrity requirements, with SME-level support provided across multiple client sites and project environments.
PLC, HMI and Automated Manufacturing Systems Validation
Hands-on experience providing CSV and CQV oversight for PLC, HMI and automated control functionality, including requirements, risk assessments, supplier documentation and qualification evidence for critical utilities, filling lines and automated manufacturing systems.
Audit Trails and User-Access Controls
Practical experience implementing and reviewing audit trails, system security and user-access controls in line with 21 CFR Part 11 and Annex 11 requirements.
FAT/SAT and Commissioning
Active participation in FAT, SAT, commissioning and qualification activities with equipment vendors and cross-functional Engineering, Automation, IT, Quality and Operations teams.
Data Integrity and Remediation
Conducting data-integrity assessments, supporting GMP system implementation, remediation and audit readiness, including cloud-based and bespoke computerized systems.
Deviations, CAPA and Change Control
Managing validation deviations, investigating non-conformances, supporting CAPAs and change controls through closure across multiple concurrent workstreams.
Temperature Mapping and Controlled-Environment Qualification
Performing temperature mapping and qualification of controlled-temperature equipment including refrigerators, freezers, cleanrooms and controlled environments.
Laboratory System Qualification
Qualifying HPLC, IcIEF, CGE, UPLC, endotoxin and particle sizer laboratory systems, integrating equipment into platforms such as Empower 3 and executing CSV and data-integrity documentation.
ValGenesis and HP ALM
Executing OQ scripts in ValGenesis and developing and executing OQ scripts using HP ALM for laboratory relocation and qualification projects.
Experience
Professional experience10+ years
Freelancer since2017
Languages
EnglishNative speaker
Project history
Led validation engineers delivering CAPEX and OPEX projects across UK pharmaceutical and life-sciences sites. Planned and coordinated CQV activities for GMP manufacturing systems, process equipment, critical utilities, automated systems and filling lines. Provided CSV and CQV oversight for PLC, HMI and automated control functionality. Developed, reviewed and approved validation plans, risk assessments, SOPs, requirements specifications, traceability matrices, IQ/OQ/PQ protocols, test scripts and reports. Provided SME support for GAMP 5, Annex 11 and 21 CFR Part 11. Supported FAT, SAT, commissioning and qualification with equipment vendors and cross-functional teams. Managed validation deviations, project priorities, resources and deliverables across multiple concurrent workstreams. Supported infrastructure and server qualification for new builds.
Delivered commissioning, qualification and validation across multiple pharmaceutical facility-build and expansion projects. Supported end-to-end qualification of a new GMP manufacturing facility including cleanrooms, critical utilities, process equipment, environmental controls, refrigerators and freezers. Developed and executed risk assessments, commissioning documentation, IQ/OQ/PQ protocols, test scripts and qualification reports. Performed temperature mapping and qualification of controlled-temperature equipment. Supported CSV and data-integrity compliance for computerized, automated and monitoring functionality. Participated in FAT, SAT, system handover and validation closeout; investigated deviations and supported CAPAs and change controls through closure.
Trained and mentored the validation team. Led CSV lifecycle activities for laboratory and computerized systems and updated SOPs and validation documentation. Conducted data-integrity assessments and supported GMP system implementation, remediation and audit readiness.