I am a freelance consultant with around 20 years of experience in the Pharmaceutical, Biopharmaceutical and API manufacturing industries, covering Validation engineering, commissioning and Qualification of equipment, clean utilities and manufacturing processes across both upstream and downstream operations. I offer a unique blend of Engineering, Quality, C&Q and regulatory know-how, with hands-on involvement across the Validation Life Cycle and experience in FAT/SAT delivery. I have worked across multiple countries, delivering projects in compliance with MHRA, FDA and EMA requirements. I am proficient with DELTA V, SCADA, Syncade, PI and synTQ, and I excel in CQV activities, risk assessments, CAPA and GMP/GDP regimes, with extensive exposure to QA tasks, audits and regulatory inspections.…

Charles Ashu

I am a freelance consultant with around 20 years of experience in the Pharmaceutical, Biopharmaceutical and API manufacturing industries, covering Validation engineering, commissioning and Qualification of equipment, clean utilities and manufacturing processes across both upstream and downstream operations. I offer a unique blend of Engineering, Quality, C&Q and regulatory know-how, with hands-on involvement across the Validation Life Cycle and experience in FAT/SAT delivery. I have worked across multiple countries, delivering projects in compliance with MHRA, FDA and EMA requirements. I am proficient with DELTA V, SCADA, Syncade, PI and synTQ, and I excel in CQV activities, risk assessments, CAPA and GMP/GDP regimes, with extensive exposure to QA tasks, audits and regulatory inspections.…

Available to hire

I am a freelance consultant with around 20 years of experience in the Pharmaceutical, Biopharmaceutical and API manufacturing industries, covering Validation engineering, commissioning and Qualification of equipment, clean utilities and manufacturing processes across both upstream and downstream operations. I offer a unique blend of Engineering, Quality, C&Q and regulatory know-how, with hands-on involvement across the Validation Life Cycle and experience in FAT/SAT delivery.

I have worked across multiple countries, delivering projects in compliance with MHRA, FDA and EMA requirements. I am proficient with DELTA V, SCADA, Syncade, PI and synTQ, and I excel in CQV activities, risk assessments, CAPA and GMP/GDP regimes, with extensive exposure to QA tasks, audits and regulatory inspections.

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Language

English
Fluent
French
Advanced
Danish
Intermediate

Work Experience

CSV QA Validation Engineer at Johnson & Johnson - Bern, Switzerland
June 1, 2024 - September 1, 2025
Review and approval of Protocols; assist in audits; work to GAMP 5 standards; review/approval of Validation plans, RTM, FMEA, CAPA; participate in daily QA planning meetings; review SIA and RA; ensure GMP compliance in investigations; liaise with SMEs to determine non-conformance severity and whether CAPA or deviation is required; investigate CSV-related deviations and draft deviations.
PQA Engineer at Fuji Film - Hillerod, Denmark
February 1, 2024 - June 1, 2025
QA CSV Engineer responsible for RA, FMEA, Validation Plans and RTM in Kneat; review/approve executed protocols; participate in meetings to leverage protocols from commissioning and qualification; ensure GMP compliance throughout QA activities.
CSV-MES Validation Engineer at Fuji Film Denmark
August 1, 2018 - October 1, 2023
Review/approval of Protocols, RA, FMEA, Validation Plans, RTM in Kneat; review/approval of executed protocols; participate in risk-based decisions for commissioning/qualification protocols; liaise with SMEs and ensure GMP compliance; approval of commissioning and qualification documentation.
PQE Engineer at Fuji Film Denmark
February 1, 2024 - June 1, 2025
QA/CSV responsibilities including RA, FMEA, Validation Plans, RTM in Kneat; review/approval of executed protocols; participate in QA meetings; ensure GMP compliance; CAPA/Deviations handling.
Commissioning and Qualification Engineer at MSD Biologics - Burgwedel, Germany
June 1, 2017 - May 1, 2018
Cycle development for autoclaves and depryogenation tunnels; authoring URS, IQ and PQ for legacy, modified and new autoclaves; test steam quality per EN285; work on depryogenation tunnel and fill-finish lines; oversee commissioning and validation of sterilization cycles.
CQV Engineer at Abbott - Weesp, Netherlands
February 1, 2016 - May 1, 2017
Strategic C&Q planning; master plans for GxP and non-GxP systems; design pre-commissioning, commissioning IQ and OQ; manage document authoring (URS, FS, DQ, FAT/SAT); oversee IQ/OQ/PQ execution and maintain audit readiness; manage deviations and change controls.
CQV Engineer at Lonza Biologics - Slough, United Kingdom
June 1, 2017 - May 1, 2018
Commissioning and qualification of controlled storage systems; thermometric mapping; author/approve PCRF; perform installation/functional confirmation protocols; coordinate risk assessments and CAPAs; ensure GMP compliance.
CQV Engineer at MSD - Milton Keynes, United Kingdom
December 1, 2015 - October 1, 2016
Strategic CQV planning; design/execute IQ/OQ/PQ protocols; lead remediation in aseptic environments; perform SIP and thermometric mapping; manage change control and CAPA actions; ensure right-first-time handover to production.
CQV Engineer at DDD Health Care - Watford, United Kingdom
January 1, 2015 - December 1, 2015
Commissioning and qualification of new homogenizer and 2000L vessels; write DQ/IQ/OQ/PQ; perform retrospective validation; conduct thermometric mapping and thermal profiling; participate in SOP updates and CAPA.
Chemical Shift Scientist at Aptuit - Abingdon, Oxfordshire
June 1, 2010 - December 1, 2011
Batch manufacturing oversight for API; operate from control room with SCADA; perform IPC, KF, RSA, RA; manage water systems (WFI, RO) and waste handling; contribute to validation of process/equipment; training and safety emphasis.
Process Technician at Wyeth Biopharma - Dublin, Ireland
September 1, 2005 - December 1, 2009
Senior process technician; monitor upstream/downstream processes, SOP adherence, batch review, CIP/SIP, change control participation, staff training, SAP/MCS/LIMS usage, equipment commissioning support.
Clean Room/Facilities Supervisor at Noonan's Services Limited - Dublin, Ireland
January 1, 2004 - September 1, 2009
Clean room supervisor and clean room marshal; oversee a team of cleaners; ensure clean room principles, weekly/monthly sanitization planning, cross-department coordination.

Education

NVQ Level 5: Project Management at PMI (PROJECT MANAGEMENT INSTITUTE - UK)
November 1, 2025 - December 1, 2025
Master of Science: Development Studies and International Relations at Aalborg University - Denmark
September 1, 1999 - March 1, 2002
Bachelor of Arts: History at University Of Buea - Cameroon
March 1, 1993 - July 1, 1996

Qualifications

NVQ Level 5: Project Management
January 11, 2030 - May 11, 2026

Industry Experience

Life Sciences, Healthcare, Manufacturing, Professional Services, Other
    paper QA VALIDATION ENGINEER

    CSV QA Validation engineer J&j, Bern, 06/2024 to 09/2025
    Johnson and Johnson - Bern, Switzerland
    CSV QA Engineer at Jansen Vaccine Bern
    ➢Review and approval of Protocols
    ➢ Assist in Audits
    ➢Working to GAMP 5 standards
    ➢Review and approval of Validation plans, RTM, FMEA, CAPA
    ➢Attending daily meetings to plan QA tasks. Help in the review and approval of , SIA and RA
    ➢Ensure GMP Compliance is adhered to throughout an investigative process
    ➢Liaise with SME to determine severity of Non conformances and determine if a Capa or Deviation is required
    ➢Investigate CSV related deviations and assist in drafting deviations.

    PQA ENGINNER, 02/2024 to 06/2025
    FUJI FILM - HILLEROD, DENMARK
    QA CSV engineer at Fuji Film Denmark
    ➢Review and approval of RA, FMEA, Validation Plans, RTM in kneat.
    ➢Review and approval of Executed protocol in kneat
    ➢Taking Part in meeting to decide leveraging of Protocols from commissioning and Qualification.

    CSV-MES VALIDATION ENGINEER, 08/2018 to 10/2023
    PQE Engineer Feb 2024-Jun 2025

    Fuji Film Denmark

    ➢Review and approval of Protocols
    ➢ Assist in Audits
    ➢Working to ASTM E2500 standards
    ➢Review and approval of Validation plans, RTM, FMEA, CAPA
    ➢Attending daily meetings to plan QA tasks.
    ➢Ensure GMP Compliance is adhered to throughout an investigative process and ensuring punches are closed.
    ➢Liaise with SME to determine severity of Non conformances and determine if a Capa or Deviation is required
    ➢Approval of Commissioning and Qualification protocols.

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