Jonathan Smith

Date:                      Jun-20 to present date

Employer:             AstraZeneca, Liverpool

Position:               Contract CSV Project Engineer

Originally contracted for a site wide Data Integrity remediation project which was extended to further support Windows upgrades and small capex projects. Each system, which included laboratory and manufacturing systems, required system specific software and operating system (re)configuration (where required), tailored to reflect intended use, ensuring compliance with FDA’s 21 CFR Part 11, EU Annex 11 and AstraZeneca policies & procedures. All systems were qualified, based on impact assessment, and assessed for residual risk to data integrity following qualification.

1. Agilent 2100 Bioanalyser (x2) – Fully qualified following updated operating system & analytical software.
2. Beckman Coulter Vi-Cell Instruments (x2) – Fully qualified, following updated operating system & analytical software.
3. Polarimeter. Relocation & qualification following changes to intended use.
4. Floor & weigh scales (Mettler & Combic) – Updated security and qualification.
5. Mettler Refractometer – Updated security and qualification.
6. Numerous Microbiology Safety Cabinets – Relocation & qualification.
7. Beckman Coulter HIAC Particle Counters – Fully qualified following updated operating system & analytical software.
8. Mettler Calibry Systems – Client PC’s, operating system upgrade and subsequent qualification
9. Applied Biosystems 3500 genetic analyser upgrade – PC, operating system and analytical software upgrade.
10. Introduction of a ThermoFisher Applied Biosystems SeqStudio Flex 24 genetic analyser – New system.
11. Hamilton Star Liquid Handling system – Hardware and software updates.
12. Charles River Multi Cartridge System (MCS) – Software upgrade.
13. Advanced Instruments OsmoTech Osmometer (x2) – New systems.
14. ThermoFisher QuBit Fluorometer – New system. 
15. Kaye ValProbe Data Logging system (x2). New system.

Date:                      Aug-19 to Jun-20

Employer:             Seqirus, Liverpool

Position:               Contract Validation Specialist

Qualification of new and existing equipment (from oversight and documenting Vendor Qualifications through to Operation Qualification) in support of a QC laboratory computerised system upgrade project.  Preparation and execution of all validation documentation for TOC analysers, Dionex Ion Chromatography system running Chromeleon 7, Peak Scientific laboratory nitrogen generator, Agilent UV-Visible Spectrophotometers, Lancer Glassware Washer and Performance Qualification of a Getinge sterility test isolator. Generation of a Validation Plan and Installation/ Operation Qualification Protocol for HMI and SCADA upgrades to two Isolators.

Date:                      Feb-18 to Aug-19

Employer:             Ipsen Biopharm, Wrexham

Position:               Validation Co-ordinator (Routine Validation)

Responsible for coordinating and performing routine periodic validation reviews and requalification activities such as SIP (filling machines, lyophiliser and fermenter), static & dynamic airflow visualisation, Lyophiliser shelf mapping. Owning and investigating validation impacting deviations. Identifying, owning and driving compliance and cost saving improvement projects. Provide validation guidance and overview of CAPEX projects which have included pure steam distribution system modifications, Clean air distribution system modifications, facility monitoring system expansions/ modifications, facility fabric modifications, new uni-directional airflow unit (UDAF), standalone thermal units, implementation (initial phases) of a site Manufacturing Execution System (MES), Planned Maintenance management system (Blue Mountain). Departmental subject matter expert for computerised systems validation and data integrity requirements. 

Validation lead for an FDA commitment to perform dynamic airflow visualisation studies of vial filling activities (all activities surrounding equipment setup, vial filling, freeze drying and over-sealing).

Date:                      Nov-16 to Feb-18

Employer:             Ipsen Biopharm, Wrexham

Position:               Validation Expert – Computer Systems Validation and Improvements

The primary purpose this role was to identify and implement improvements in order to strengthen the qualification process, with particular focus on the validation life cycle of computerised systems and embedding data integrity into related business processes at the earliest phase of system identification and implementation. 

Introduction of a process for logging, assessing (based on a return on business investment), prioritising, assigning and tracking all improvements identified by the Validation and Qualification department. Involved with regulatory commitments and a departmental independence project which have required planning and qualification of clean rooms, process equipment (vial capping machine) and clean utility (clean air, pure steam and WFI) modifications.

Date:                      Jul-14 to Nov-16

Employer:             Seqirus (CSL), Liverpool - (formerly Novartis Vaccines)

Position:               Senior Primary Validation Specialist (Validation Lead - Formulation Project)

The move from previous managerial positions to the role of senior validation specialist was to broaden my validation experience and exposure but also to learn more about the business and process. Facilitated weekly departmental meetings in order to monitor VMP compliance (re-validations and re-evaluations), CAPAs/DRs, Change Controls, all open validation documentation, associate/resource loading and work load allocations.

Validation lead for an FDA commitment to improve cleaning methods applied to egg inoculation machines (Embrex). Previous experience within QC was invaluable to this project in identifying all necessary activities required to support the project and ensure the commitment was met on time and in full.

Validation lead during contract filling CMO audit located in Madrid.

Validation lead for the introduction of a new formulation facility and transfer of existing formulation processes from Italy to the Liverpool site, which included buffer, adjuvant and product formulations. As part of this role I was responsible for the recruitment (and subsequent management) of all team members (contractors) in order to ensure all facilities, clean utilities, equipment and processes (including cleaning, sanitisation, sterilisation and product processing) were qualified to allow successful regulatory (EU/US and Canada) submission in 2017.

Date:                      Feb-13 to Jul-14

Employer:             Novartis Vaccines, Liverpool

Position:               E-Compliance Manager (Quality Excellence Program – QEP)

I took on the role of eComplaince (electronic data compliance) manager as part of the Novartis V&D QEP program. Following my QEP rotation I was awarded the role full time. 

Responsible for ensuring all computerised systems used for GMP activities comply with current Novartis and regulatory expectations, in particular 21 CFR Part 11 and EU annex 11. Site lead for the divisional data integrity improvement plan rollout which required good communication between local site and divisional representatives at varying levels of authority. Attendance and participation at the weekly divisional computer system validation committee and data integrity teleconferences. All communications between local and global representatives helped to ensure consistent approaches were adopted, where possible, and to ensure issues identified at other sites were prevented locally, and vice versa. 

Introduction of a more structured and proceduralised foundation to the department, providing greater control, visibility and monitoring of critical departmental activities. As a result the new departmental framework allowed greater integration with existing site and departmental processes.

One of two hosts during the data integrity audit which took place in October 2013 where a satisfactory rating was received for the site.

Date:                      Oct-12 to Feb-13

Employer:             Novartis Vaccines, Liverpool

Position:               QC Validation Manager

Responsible for planning, coordinating and reporting all QC Validation activities involved in the transfer of secondary manufacturing release and stability testing from Italy to Liverpool relating to all egg based influenza vaccine products. Ensuring all local, global and regulatory standards were adhered to whilst demonstrating specialist knowledge transfer and site-to-site method alignment with supporting statistical equivalence data in order to guarantee a solid and compliant method transfer package was achieved. 

Responsible for overseeing all CSV related laboratory system implementation projects from a QC Validation perspective to assess impact on routine operations, existing validation and on-going projects. Equipment qualification subject matter expert for Novartis V&D Liverpool

Date:                      Jul-10 to Oct-12

Employer:             Novartis Vaccines, Liverpool

Position:               QC Validation Lead

Manage a team of staff to ensure the Quality Control Department is fully compliant in all routine operations performed. Responsible for coordinating all QC Validation activities supporting marketed product testing, ensuring all work is completed in a compliant and timely manner to agreed rolling plans. Review/ approve all protocols and reports for the department. Maintain all QC VMP’s and associated metrics. Ensure all previously completed validation activities are periodically evaluated to assess for continued adherence to regulatory and company standards. Evaluate change control requests for impact on validated systems and processes. 

Date:                      Aug-09 to Jun-10

Employer:             Novartis Vaccines, Liverpool

Position:               Interim QC Validation Manager 

To coordinate and review routine validation activities within parts of the Quality Control areas to ensure that the appropriate site and regulatory standards are applied and work is completed according to project plans.

Date:                      Sep-07 to Jul-09

Employer:             Novartis Vaccines, Liverpool

Position:               QC Validation Technical Specialist 

Responsible for coordinating and supervising a team of Novartis staff and contractors, involved in the relocation of all equipment, assays, procedures and processes required by the Quality Control department (Analytical Chemistry, Bio-Assay, Raw Materials and Microbiology) to a new manufacturing site in Speke, Liverpool. 

Date:                      Oct-04 to Aug-07

Employer:             Novartis Vaccines (formerly Chiron Vaccines)

Position:               QC Validation Technician 

Main activities and tasks were to support and perform qualification studies, retrospective and prospective, for all equipment according to cGMP within the Quality Control Group (Analytical Chemistry, Primary/ Raw Materials, Microbiology & Bio-Assay). 

Date:                      Jul-02 to Aug-03

Employer:             Chiron Vaccines (formerly Powderject Pharmaceuticals) 

Position:               Placement student, Analytical Chemistry Lab Technician

Analysis of pharmaceutical water for injection (sampling, conductivity, wet chemistry, TOC). Preparation and execution of the equipment qualification protocols (IQ/ OQ/ PQ), followed by the preparation and execution of assay validation protocols and reports, all of which were completed in compliance with cGMP and ICH guidelines. 

EDUCATION: 

Harry Carlton ComprehensiveSchool, East Leake (Leics)                              Sep-93       Jun-98

Harry Carlton School Sixth Form, East Leake                                                  Sep-98       Jun-00

Sheffield Hallam University - BSc (Hons) Biomedical Chemistry                     Sep-00       Jun-04

QUALIFICATIONS:

Degree (2004):                BSc (Hons) Biomedical Chemistry – 2(i) (upper second class)

A’ Levels (2000):            Chemistry & Biology