John Coombs Email & Phone Number

London, United Kingdom

Leading a team of dedicated professional life science staff on complex and varied projects for new facilities and equipment to periodic review and re-qualification and routine re-validation in the biotech industry. Addressing change controls, CAPA´s and risk assessemnts in various forms from FMEA to company specific systems including GMP system and.

Basel Area, Switzerland

Development and implementation of engineering compliance documentation, covering a diverse range of engineering disciplines. Technical Guidance Documents, Quality Directives and SOP's.

Madrid Area, Spain

Managing a compact team of QA technicians to perform re-validation activities, managing CAPAs and RAs. Utilising the teams skills and experience for continuous improvement of operations and supporting new project initiatives for existing and new equipment and systems.

Switzerland

Leading a small team of engineers in commissioning and qualification activities for Biotech facility.Includes recruitment training and familiarisation for local resources. Close cooperation with validation and quality units to ensure smooth transition from implementation to hand-over. Developing strategies to transition from clinical trials environment to.

Noord Holland, Netherlands

Working to very tight schedule with minimal resources to qualify small biotech facility upgrade. Working closely with QA and operations to maintain sxchedule and enable timely manufacture of batches post qualification.

Manager for the IQ, OQ, PQ, including cleaning validation. Managing Jacobs Engineering and other validation sub-contractors and SP staff qualification teams for new flu vaccine manufacturing facility in Swiftwater, PA.Presentations to Project stakeholders on progress, staffing and technical details. Preparation of VMP's, sub-VMP's and authoring procedure.

Providing global Validation consultancy services to Pharmaceutical and Biotech industries. Working directly with Clients on New and Renovation Projects during Commissiong and Qualification phase.Writing, reviewing and advising on qualification documentation.

Applying quality assurance to the project team through GMP/GDP Training. Working with eningeers to ensure alignment between construction check records and the Clients (MSD) qualification protocols (Highly leveraged).Planning, organizing and attending FAT for equipment suppliers.Developing automated check records generation system based upon engineering.

Managing the project qualification teams based in Sweden (Pharmadule)and US during design and construction. Managing the qualification in Singapore (Pharmadule and Foster Wheeler/ PMG)during post construction activities. Rolling out new C&Q approach developed by MSD and presenting and training the teams involved. wortkin g closely iwth QA throughout to.

Recruited, managed and trained a team of validation engineers to support the MSD High Shear Module in Pavia, Italy. Working closely with and mentored by the JEG Regulatory Compliance Manager (Europe and Asia)

Prepared protocols and plans to qualify and validate biotech equipment and facilities including process systems, utilities, HVAC. Recruiting a local team to write and execute qualification documents DQ, IQ, OQ, PQ. Coordintation of commissioning and qualification teams for new build facilities. Recriut and lead a small high caliber team to review past.

TBA

Recruited and managed a team appointing sub-team leaders for a 37 man strong organization to address retrospective qualification and validation preparing the site for GMP inspection by FDA and EMEA. Areas included secondary manufacture production, HVAC, calibration, maintenance, clean utilties and drawings.

Managed a multi-disciplined team of technicians and engineers to optimise availabiility of production equipment and facilties for secondary manufacturing site. Organised training and education needs to develop the technician role for multidiscipline cover during shift working schedules. Identified and developed process improvement projects to increase.

Manage turn key projects for the pharmaceutical and chemical manufacturing industry

Certified Green Belt, Lean Six-Sigma

M.Sc., Engineering Validation

Applied Mathematics

Activities and Societies: OU

Physics

Activities and Societies: OU

Organic Chemistry

Activities and Societies: OU