Available to hire
I’m a dynamic CSV and data integrity consultant with over a decade of experience in computer system validation, data integrity, project management, and quality assurance across diverse industries. I specialize in managing complex CSV processes, 21 CFR Part 11 assessments, and Agile delivery, helping organizations achieve regulatory compliance and operational efficiency.
I am passionate about applying CSV best practices to drive compliance, audit readiness, and continuous improvement. My hands-on experience spans MES implementations, ERP upgrades, documentation, risk assessments, and validation life cycles, and I thrive in collaborative, stakeholder-driven environments.
Skills
Experience Level
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Intermediate
Intermediate
Intermediate
Language
English
Fluent
Work Experience
Test, Validation & Quality Manager (freelance) at Novo Nordisk IT A/S
November 1, 2010 - June 1, 2014Managed validation of IT test processes, data integrity, project management, remediation, infrastructure qualification, quality and compliance and deviation management. Oversaw alignment with regulatory requirements and ensured timely delivery of validation activities for major IT systems and MES interfaces.
CSV Consultant / GMP Advisor at Friesland Campina B.V
November 1, 2014 - November 1, 2014Provided GMP/CVS guidance for SAP CSV implementation and global SAP/ERP rollout; assessed CSV systems for compliance with GMP, 21 CFR Part 11 considerations, and validated data flows.
SAP Lead Validation Consultant at Zoetis Inc
March 1, 2015 - May 1, 2015Lead validation activities for SAP-related deployments, including test planning, risk management, and end-user testing across O2C, M2D, P2P modules; scripted and tracked validation lifecycle.
CSV Site Owner / Test Manager at Gilead Life Sciences
June 1, 2015 - February 1, 2016Headed CSV validation across global deployment; managed test plans, risk mitigation, and data integrity remediation across sites in London; collaborated with GMP and FDA expectations.
CSV / Data Integrity Consultant at Teva Pharmaceuticals
March 1, 2016 - June 1, 2016Risk assessments and data integrity remediation for PLC/SCADA/HMI systems; conducted site audits and action plans to address 483 concerns.
CSV Automation Consultant at Biogen
June 1, 2016 - October 1, 2016Spearheaded validation and automation for new generation manufacturing; defined corporate CSV automation strategy involving DeltaV, PI Osisoft, Dynamo, etc.
SAP Test Manager (Freelance) at Merck KGaA
February 1, 2017 - August 1, 2017Directed validation and project management of SAP/ERP S4/HANA rollout; managed test & risk, including FMEA, Jama/HPALM usage across multiple releases.
CSV Owner / Test Manager at Merck Sharp & Dohme
September 1, 2017 - December 1, 2017Oversaw automation CSV test practices for Ebola vaccine project, including autoclaves, analyzers, EMS; maintained GxP compliance.
CSV Specialist at Hollister Inc / Dansac A/S
May 1, 2018 - August 1, 2018Medical device software remediation; gap analysis to ISO 13485:2016; coordination of black box testing for PLC/HMI/SCADA.
CSV Subject Matter Expert at Leo Pharmaceuticals A/S
August 1, 2018 - January 1, 2019Managed CSV for FDA inspection readiness; remediation of ARISg, eTMF/Veeva, eDMS and pharmacovigilance systems.
CSV Consultant (Remote) at Perrigo
August 1, 2023 - November 1, 2023Coordinated validation for SAP ERP upgrade, Veeva Vault, TVT; conducted 21 CFR Part 11 assessments.
CSV / Project Management Consultant (Remote) at Sapphiros
December 1, 2023 - June 1, 2024Orchestrated project management, validation, and QA of CSV IT practices for ERP remediation/integration projects.
Automation Consultant (Remote) at Boehringer Ingelheim
May 1, 2023 - December 1, 2023Validation and automation for MES (Werum PAS-X), Zenon and DiVAL projects; created validation strategy and risk analysis.
CSV Consultant (Remote) at Idorsia Pharmaceuticals
July 1, 2022 - December 1, 2022SAP MDG pilot program; coordinated test team, documentation and strategies using PIMS (Valgenesis).
CSV Consultant (Remote) at Zimmer Biomet
January 1, 2022 - June 1, 2022Overhauled validation and remediation for SAP S4/HANA rollout; included GRC, Proxima DACH, automation and change management.
CSV Expert (Remote) at Essity AB
July 1, 2022 - December 1, 2022Spearheaded validation for 21 CFR Part 11 assessments for eWOW SAP S4/HANA project; MDG, GRC, ADM and Tosca usage.
CSV Consultant (Remote) at Sartorius Stedim Biotech
July 1, 2020 - December 1, 2021Validation and QA for Sparta CAPA Trackwise initiative; involved SaaS, MES, LIMS, IAM, and documentation across multiple tools.
Project Quality Management Consultant (hybrid freelance) at Novo Nordisk Engineering Kalundborg
March 1, 2025 - November 1, 2025Defined verification strategies, test planning, FATs/SATs/UATs, and supplier QA deliverables for large automation/IT projects.
CSV / Data Integrity Consultant (Freelance) at Regeneron
July 1, 2024 - December 1, 2024Enterprise System Data Integrity Assessments and remediation; implemented process improvements across FactoryTalk, Discoverant, Oracle.
Education
BSc (Hons) Biotechnology at University of Abertay Dundee
January 11, 2030 - February 17, 2026Qualifications
21 CFR Part 11 assessments
January 11, 2030 - February 17, 2026GAMP5
January 11, 2030 - February 17, 2026EDMS & QMS implementation
January 11, 2030 - February 17, 2026Eudralex Vol 4 Annex 11
January 11, 2030 - February 17, 2026Industry Experience
Life Sciences, Healthcare, Manufacturing, Professional Services, Software & Internet
Skills
Experience Level
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Intermediate
Intermediate
Intermediate
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