Computer Systems Validation / Data integrity / Regulatory Compliance / GMP / GAMP 5
Aktualisiert am 10.11.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 05.01.2026
Verfügbar zu: 100%
davon vor Ort: 100%
Computer System Validation (CSV) Engineer
GxP Compliance
GMP
LIMS
Project Management
Project Delivery
Vendor Management
Stakeholder Management
TrackWise
Veeva
Sample Manager
Deviation and CAPA Management
Change Control Management
Systems Implementation
Backup Management
System Restoration

Einsatzorte

Einsatzorte

Frankfurt am Main (+50km) Berlin (+50km) Munich (+50km) Mannheim (+50km) Basel (+50km) Zurich (+50km) Visp (+50km)
Deutschland, Schweiz
möglich

Projekte

Projekte

1 year 6 months
2024-06 - now

Contributed to the OMNIS Project

Laboratory IT Systems Specialist (CSV)
Laboratory IT Systems Specialist (CSV)
  • Contributed to the OMNIS Project, integrating laboratory systems across QC labs after the Novo Nordisk site acquisition.
  • Authored the Validation Plan (VPL) and User Requirements Specification (URS) for OMNIS.
  • Drafted test functions for software qualification, supporting paperless execution in ValGenesis.
  • Managed responsibilities across Alkermes and Novo Nordisk during transition.
  • Collaborated with IT, Project Team, Lab Management, and vendor to ensure OMNIS met operational and regulatory needs (FDA 21 CFR Part 11, EU Annex 11 and EU Annex 22). 
Novo Nordisk (Athlone)
3 years
2022-02 - 2025-01

Develop qualification documentation

LIMS - Laboratory IT Systems Specialist
LIMS - Laboratory IT Systems Specialist
  • Develop qualification documentation, including Requirements Specification, Validation Project Plan, System Based Risk Assessment, Configuration Specification, GxP test scripts (OPQ) and RTM for upgrade to SampleManager LIMS 21.0
  • Planned, executed and documented SAT testing for SampleManager LIMS 21.0
  • Updated and enhanced related SOPs for SampleManager 21.0 in Veeva Vault.
  • Collaborated closely with QC Analytical group for testing of SampleManager LIMS 21.0
  • Created and managed project change control activities and related implementation actions in TrackWise Digital (QMS) for SampleManager LIMS 21.0
  • Conduct thorough periodic reviews including data reviews of existing benchtop systems in the laboratory, ensuring continuous compliance and identifying areas for improvement.
Alkermes (Athlone)
9 months
2021-03 - 2021-11

Qualification of Tiamo 3.0 and controlled equipment

QC CSV Engineer
QC CSV Engineer
  • Qualification of Tiamo 3.0 and controlled equipment including pH conductivity meters and titrators.
  • Qualification of Vaya Raman handheld Spectrometer for raw materials identification.
  • Review and approval of GxP documentation including SOPs, Configuration Specifications and IOQ.
  • Collaboration with QA, QC and AIS teams in the qualification of computerised systems.
  • Additional assistance provided to PEV and AIS teams for the qualification of EndoScan-V software for Charles River ELx808 BioTek, Endosafe nextgen-MCS and SpectraMax M5e.
WuXi Biologics (Dundalk)
7 months
2020-07 - 2021-01

Develop and implement procedures and processes

QC CSV Specialist
QC CSV Specialist
  • Develop and implement procedures and processes for the complete QC computer systems validation lifecycle.
  • Planned and managed cGMP validation test and documentation phase of the implementation. Ensuring seamless execution and successful validation of critical computerised systems within the QC department.
  • FMEA risk assessment for introduction of computerised systems.
  • Qualification of spectrometry and chromatography computer systems, including Tiamo 3.0, Shimadzu UV-1900 UV-Vis/LabSolutions, SEBIA Hydasys 2 Scan/Phoresis and Gerhardt Vapodest 500 Carousel/CG Dashboard.
  • IQOQ pre-approval of Thema4 control software for Fedegari autoclave.
  • Management of deviations, CAPA?s and change controls related to the QC computer systems.
  • Participation in international project teams relating to QC.
Grifols (Dublin)
7 months
2020-01 - 2020-07

Development of new Configuration Specs

QC IT/CSV Engineer
QC IT/CSV Engineer
  • Development of new Configuration Specs, Work Instructions and SOPs for IT applications being used on Instrument PCs in the QC Labs.
  • Collaboration with QA IT team to align and standardise approach for compliance and qualification of computerised systems.
  • Review and approval of GxP documentation including SOPs, URS, Configuration Specifications. IOQ and Summary Reports.
  • Configuration of systems software, user accounts and Secure Desktop, optimising system performance and data security within the laboratory environment.
  • Implementation and testing of backups for systems in Acronis.
  • Planning, execution and documenting of IOQ protocols as part of the qualification of computerised laboratory systems.
  • Review of executed IOQ protocols for CTUs (Fridges, Freezers and Incubators) and write-up of summary report for equipment release.
  • Participation in facilitated reviews of URS, IOQ and RTM documentation.
  • Participation in Operational Readiness meetings with QC department.
MSD (Dublin)
9 months
2019-05 - 2020-01

Evaluation of systems/equipment

QC CSV Engineer
QC CSV Engineer
  • Evaluation of systems/equipment in accordance with cGMPs, FDA 21 CFR Part 11, USP and other regulatory requirements.
  • Administration of computerised systems including Empower, chromatography and spectrometry.
  • Participation in QC capital expenditure budget/strategic planning meetings to discuss requirements for new laboratory equipment.
  • Liaising with external 3rd party suppliers to identify costings for hardware, software, consumables and vendor IQ/OQ execution as part of QC capital expenditure budget.
  • Working closely with user groups to evaluate, develop, implement and maintain systems to improve processes, streamline workflow, and generally increase productivity in laboratory operations.
  • Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
  • Presenting new equipment at Change Control Review Board (CCRB) for authorisation.
  • Writing wraparound IQ/OQ and PQ equipment validation protocols; URS, RTM, QSR and associated reports.
  • Executing Periodic Review and Revalidation of Computer Systems and Laboratory Equipment.
  • TrackWise (QMS) deviation, CAPA and change control management.
  • Accompany and ensure all documentation is completed prior and during vendor engineers site visits when vendors perform routine calibration, qualification, requalification and/or preventative maintenance activities in the QC laboratory.
  • Managing and supporting vendors during site visits, in conjunction with Flex system.
  • Report writing for investigations.
  • Completion of calibration and maintenance tasks in CMMS Infor, relating to equipment in the QC labs.
Alexion (Dublin Manufacturing Facility)
7 months
2018-06 - 2018-12

Administration of Biopharmaceutical analytical platform applications

IT Laboratory Systems Engineer
IT Laboratory Systems Engineer
  • Onsite support for over 300 laboratory staff, on more than 50 GxP business critical systems.
  • Administration of Biopharmaceutical analytical platform applications including SampleManager LIMS, GE Healthcare Biacore C, Beckman Coulter CE (Capillary Electrophoresis), HIAC 9703+ Liquid Particle Counter, Protein Simple iCE3, Sievers M9 TOC Analyser, Biorad Densitometer and Vitek MS.
  • Performance monitoring of benchtop laboratory instrument PCs and applications.
  • Maintaining existing and development of new application SOPs (Standard Operating Procedures), Configuration Specifications and Work Instructions; contributing to change control in the Document Control and Archiving (DCA) System ? Emerson Syncade.
  • Liaising with external 3rd party suppliers of IT applications at a technical level.
  • Liaising with other team?s onsite including CSV, IT Projects, QA, QC and QCTS.
  • Managing and supporting Vendor engineers during site visits for Performance Monitoring/Verification.
  • Reviewing access to laboratory systems in Active Directory and via remote VNC.
  • Manual backups of laboratory standalone systems including SQL Server 2012.
  • Knowledge of CSV (Computer Systems Validation) / GAMP 5; its application and automated system life cycle.
  • Developed a new Work Instruction for the Performance Monitoring of laboratory instrument PCs, contributing to continuous service improvement, streamlining key tasks, and reducing completion time for colleagues in the Automation & IT team. 
Bristol-Myers Squibb (Dublin)
11 months
2017-08 - 2018-06

Providing remote/onsite operations support

Service Operations Associate
Service Operations Associate
  • Providing remote/onsite operations support across more than 40 sites for 3000 staff, on more than 20 systems. Including Greater Manchester Fire and Rescue Service.
  • Remote support, troubleshooting and systems analysis via SCCM Remote Control Viewer.
  • Deploying and re-imaging of devices with Windows 10 and software through SCCM 2012.
  • Applying project management principles to monitor and control system deployments.
  • Collaborating with 3rd party support to investigate hardware and software problems.
  • Maintenance of users, groups and computer accounts in Active Directory.
  • Administration of incidents/problems in Supportworks service management software.
Greater Manchester Combined Authority (Manchester)
1 year 5 months
2016-04 - 2017-08

Remote and onsite operations support

ICT Engineer
ICT Engineer
  • Remote and onsite operations support for staff numbering 3500 across all council sites.
  • Administration/support of Citrix user profiles through Citrix Director (shadowing and resetting).
  • Enterprise application support for Citrix Director, FortiClient VPN, Clearswift and Egress Switch.
  • Manage on-boarding, retirement/decommissioning and relocation of equipment.
  • Image deployment of Windows 10 operating system and software using SCCM 2012.
  • Applying project management principles to monitor and control system deployments.
  • Supporting and repair of PCs, laptops and tablets (Dell, HP and Microsoft) on wireless/VPN.
  • Created and maintained users, groups and computer accounts in Active Directory.
  • Liaising with 3rd party support to investigate, diagnose network, hardware and software problems. 
Barnsley Metropolitan Borough Council (Barnsley)
1 year 5 months
2014-12 - 2016-04

Requirements gathering/scoping, end-to-end testing

Clinical Systems Administrator
Clinical Systems Administrator
  • Technical lead and support of departmental Diagnostic Genetics I.T. applications/infrastructure for 120 staff.
  • Requirements gathering/scoping, end-to-end testing, implementation and sign off for Next Generation Sequencing, New Born Screening and GeneMapper projects.
  • Facilitated workshop for New Born Screening project, to show stakeholders interface and design layout of new system.
  • Attendance of multi-disciplinary team meetings with Informatics team leads.
  • Support of laboratory equipment (including SATO barcode scanners & label printers / FluidX barcode readers) and associated software. Training laboratory staff on use of equipment.
  • Application installation/implementation, configuration and management of departmental clinical/ genetics systems including STARLIMS (web servers/interfaces and underlying SQL databases),
  • Managing and supporting vendors during site visits.
  • Implementation of md5 checksums to verify data integrity for data transfers.
  • Administration, monitoring and backup of departmental servers.
  • Implemented change and release management controls to plan for system outages while updating servers and releasing new versions of software, communicating changes to system users.
  • Built Lenovo RD650 servers, installing Linux Ubuntu for New Born Screening and NGS projects.
  • Maintenance and management of HP Proliant Gen 6-8 server hardware.
  • Applying project management principles to monitor and control Windows 7 rollout.
Sheffield Children?s Hospital NHS Foundation Trust / Sheffield Diagnostic Genetics Service (Sheffield)

Aus- und Weiterbildung

Aus- und Weiterbildung

  • BSc (Hons) Computing (2:1): University of Central Lancashire
  • Futures Gold Award: University of Central Lancashire
  • Computing (Diploma of Higher Education): Manchester Metropolitan University
  • GNVQ Advanced Information Technology (Distinction)
  • GCSE Mathematics (B), English Language (B) Information Systems (B)


PROFESSIONAL TRAINING CERTIFICATES

  • IASSC: Lean Six Sigma Green Belt - Currently Pursuing
  • ITIL: IT Service Management ? Foundation (Self Study)
  • PRINCE2: Project Management ? Foundation (Self Study)
  • STARLIMS (Configuration Course): Pass (STARLIMS / Abbott Informatics Europe Ltd)
  • NVQ Level II: Customer Service (Derby College)
  • NVQ Level II: Information Technology (Link Training)

Kompetenzen

Kompetenzen

Top-Skills

Computer System Validation (CSV) Engineer GxP Compliance GMP LIMS Project Management Project Delivery Vendor Management Stakeholder Management TrackWise Veeva Sample Manager Deviation and CAPA Management Change Control Management Systems Implementation Backup Management System Restoration

Produkte / Standards / Erfahrungen / Methoden

PROFILE

Accomplished Validation/CSV Engineer with a proven track record in successful validation and qualification of diverse laboratory systems and equipment. Key strengths include: applying strong technical knowledge to ensure successful project delivery, engaging with key stakeholders to deliver high performance cost effective solutions. Demonstrated expertise in project management and driving process improvements to optimise laboratory operations. Committed to fostering a culture of compliance and continuous improvement. Harnessing a strong business awareness to ensure System solutions align with organisational strategy and deliver the expected customer benefits. Seeking to leverage extensive experience and technical proficiency in a Senior Validation/CSV Engineer role at a dynamic organisation focused on innovation and excellence in the pharmaceutical and biotechnology sectors. 


KEY SKILLS

  • Computer Systems Validation
  • Vendor Management
  • Stakeholder Management
  • Deviation and CAPA Management 
  • Change Control Management 
  • Regulatory Compliance / Data Integrity
  • Project Management and Delivery
  • System Implementations
  • Backup Management, reporting and recovery 
  • System Restoration 


CAREER HIGHLIGHTS

  • Successfully assisted in the qualification of the upgraded SampleManager LIMS 21.0 system, ensuring its efficient implementation and site-wide utilisation at Alkermes Athlone.
  • Qualification of SCIEX PA 800 plus Capillary Electrophoresis (CE), Charles River ELx808 BioTek Microplate Reader & Endosafe nextgen-PTS and BioMérieux BACT/ALERT systems in the QC laboratories at MSD Dublin. Execution of IOQ protocols for and reports for CTUs (Fridges, Freezers and Incubators) for qualification in the QC laboratories in Dublin. 
  • Proficiently validated DataAnalyst (supporting software package for Lasair III particle counters), SPECTRAmax 190 Microplate Reader, Sievers M9 TOC Analyser and Dionex ICS-5000 systems in the QC laboratories at Alexion Dublin. 
  • Successfully managed projects involving the installation and configuration of Lenovo RD650 servers with Linux Ubuntu, for NGS (Next Generation Sequencing) and New Born Screening projects at Sheffield Diagnostic Genetics Service. Contributed to increasing departmental budget by 25%.
  • Implementation of new server hardware for Next Generation Sequencing and New Born Screening projects, installation of new GeneMapper application software and data migration at Sheffield Diagnostic Genetics Service. Achieved improved user experiences and business outcomes through seamless system enhancements. 

Einsatzorte

Einsatzorte

Frankfurt am Main (+50km) Berlin (+50km) Munich (+50km) Mannheim (+50km) Basel (+50km) Zurich (+50km) Visp (+50km)
Deutschland, Schweiz
möglich

Projekte

Projekte

1 year 6 months
2024-06 - now

Contributed to the OMNIS Project

Laboratory IT Systems Specialist (CSV)
Laboratory IT Systems Specialist (CSV)
  • Contributed to the OMNIS Project, integrating laboratory systems across QC labs after the Novo Nordisk site acquisition.
  • Authored the Validation Plan (VPL) and User Requirements Specification (URS) for OMNIS.
  • Drafted test functions for software qualification, supporting paperless execution in ValGenesis.
  • Managed responsibilities across Alkermes and Novo Nordisk during transition.
  • Collaborated with IT, Project Team, Lab Management, and vendor to ensure OMNIS met operational and regulatory needs (FDA 21 CFR Part 11, EU Annex 11 and EU Annex 22). 
Novo Nordisk (Athlone)
3 years
2022-02 - 2025-01

Develop qualification documentation

LIMS - Laboratory IT Systems Specialist
LIMS - Laboratory IT Systems Specialist
  • Develop qualification documentation, including Requirements Specification, Validation Project Plan, System Based Risk Assessment, Configuration Specification, GxP test scripts (OPQ) and RTM for upgrade to SampleManager LIMS 21.0
  • Planned, executed and documented SAT testing for SampleManager LIMS 21.0
  • Updated and enhanced related SOPs for SampleManager 21.0 in Veeva Vault.
  • Collaborated closely with QC Analytical group for testing of SampleManager LIMS 21.0
  • Created and managed project change control activities and related implementation actions in TrackWise Digital (QMS) for SampleManager LIMS 21.0
  • Conduct thorough periodic reviews including data reviews of existing benchtop systems in the laboratory, ensuring continuous compliance and identifying areas for improvement.
Alkermes (Athlone)
9 months
2021-03 - 2021-11

Qualification of Tiamo 3.0 and controlled equipment

QC CSV Engineer
QC CSV Engineer
  • Qualification of Tiamo 3.0 and controlled equipment including pH conductivity meters and titrators.
  • Qualification of Vaya Raman handheld Spectrometer for raw materials identification.
  • Review and approval of GxP documentation including SOPs, Configuration Specifications and IOQ.
  • Collaboration with QA, QC and AIS teams in the qualification of computerised systems.
  • Additional assistance provided to PEV and AIS teams for the qualification of EndoScan-V software for Charles River ELx808 BioTek, Endosafe nextgen-MCS and SpectraMax M5e.
WuXi Biologics (Dundalk)
7 months
2020-07 - 2021-01

Develop and implement procedures and processes

QC CSV Specialist
QC CSV Specialist
  • Develop and implement procedures and processes for the complete QC computer systems validation lifecycle.
  • Planned and managed cGMP validation test and documentation phase of the implementation. Ensuring seamless execution and successful validation of critical computerised systems within the QC department.
  • FMEA risk assessment for introduction of computerised systems.
  • Qualification of spectrometry and chromatography computer systems, including Tiamo 3.0, Shimadzu UV-1900 UV-Vis/LabSolutions, SEBIA Hydasys 2 Scan/Phoresis and Gerhardt Vapodest 500 Carousel/CG Dashboard.
  • IQOQ pre-approval of Thema4 control software for Fedegari autoclave.
  • Management of deviations, CAPA?s and change controls related to the QC computer systems.
  • Participation in international project teams relating to QC.
Grifols (Dublin)
7 months
2020-01 - 2020-07

Development of new Configuration Specs

QC IT/CSV Engineer
QC IT/CSV Engineer
  • Development of new Configuration Specs, Work Instructions and SOPs for IT applications being used on Instrument PCs in the QC Labs.
  • Collaboration with QA IT team to align and standardise approach for compliance and qualification of computerised systems.
  • Review and approval of GxP documentation including SOPs, URS, Configuration Specifications. IOQ and Summary Reports.
  • Configuration of systems software, user accounts and Secure Desktop, optimising system performance and data security within the laboratory environment.
  • Implementation and testing of backups for systems in Acronis.
  • Planning, execution and documenting of IOQ protocols as part of the qualification of computerised laboratory systems.
  • Review of executed IOQ protocols for CTUs (Fridges, Freezers and Incubators) and write-up of summary report for equipment release.
  • Participation in facilitated reviews of URS, IOQ and RTM documentation.
  • Participation in Operational Readiness meetings with QC department.
MSD (Dublin)
9 months
2019-05 - 2020-01

Evaluation of systems/equipment

QC CSV Engineer
QC CSV Engineer
  • Evaluation of systems/equipment in accordance with cGMPs, FDA 21 CFR Part 11, USP and other regulatory requirements.
  • Administration of computerised systems including Empower, chromatography and spectrometry.
  • Participation in QC capital expenditure budget/strategic planning meetings to discuss requirements for new laboratory equipment.
  • Liaising with external 3rd party suppliers to identify costings for hardware, software, consumables and vendor IQ/OQ execution as part of QC capital expenditure budget.
  • Working closely with user groups to evaluate, develop, implement and maintain systems to improve processes, streamline workflow, and generally increase productivity in laboratory operations.
  • Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
  • Presenting new equipment at Change Control Review Board (CCRB) for authorisation.
  • Writing wraparound IQ/OQ and PQ equipment validation protocols; URS, RTM, QSR and associated reports.
  • Executing Periodic Review and Revalidation of Computer Systems and Laboratory Equipment.
  • TrackWise (QMS) deviation, CAPA and change control management.
  • Accompany and ensure all documentation is completed prior and during vendor engineers site visits when vendors perform routine calibration, qualification, requalification and/or preventative maintenance activities in the QC laboratory.
  • Managing and supporting vendors during site visits, in conjunction with Flex system.
  • Report writing for investigations.
  • Completion of calibration and maintenance tasks in CMMS Infor, relating to equipment in the QC labs.
Alexion (Dublin Manufacturing Facility)
7 months
2018-06 - 2018-12

Administration of Biopharmaceutical analytical platform applications

IT Laboratory Systems Engineer
IT Laboratory Systems Engineer
  • Onsite support for over 300 laboratory staff, on more than 50 GxP business critical systems.
  • Administration of Biopharmaceutical analytical platform applications including SampleManager LIMS, GE Healthcare Biacore C, Beckman Coulter CE (Capillary Electrophoresis), HIAC 9703+ Liquid Particle Counter, Protein Simple iCE3, Sievers M9 TOC Analyser, Biorad Densitometer and Vitek MS.
  • Performance monitoring of benchtop laboratory instrument PCs and applications.
  • Maintaining existing and development of new application SOPs (Standard Operating Procedures), Configuration Specifications and Work Instructions; contributing to change control in the Document Control and Archiving (DCA) System ? Emerson Syncade.
  • Liaising with external 3rd party suppliers of IT applications at a technical level.
  • Liaising with other team?s onsite including CSV, IT Projects, QA, QC and QCTS.
  • Managing and supporting Vendor engineers during site visits for Performance Monitoring/Verification.
  • Reviewing access to laboratory systems in Active Directory and via remote VNC.
  • Manual backups of laboratory standalone systems including SQL Server 2012.
  • Knowledge of CSV (Computer Systems Validation) / GAMP 5; its application and automated system life cycle.
  • Developed a new Work Instruction for the Performance Monitoring of laboratory instrument PCs, contributing to continuous service improvement, streamlining key tasks, and reducing completion time for colleagues in the Automation & IT team. 
Bristol-Myers Squibb (Dublin)
11 months
2017-08 - 2018-06

Providing remote/onsite operations support

Service Operations Associate
Service Operations Associate
  • Providing remote/onsite operations support across more than 40 sites for 3000 staff, on more than 20 systems. Including Greater Manchester Fire and Rescue Service.
  • Remote support, troubleshooting and systems analysis via SCCM Remote Control Viewer.
  • Deploying and re-imaging of devices with Windows 10 and software through SCCM 2012.
  • Applying project management principles to monitor and control system deployments.
  • Collaborating with 3rd party support to investigate hardware and software problems.
  • Maintenance of users, groups and computer accounts in Active Directory.
  • Administration of incidents/problems in Supportworks service management software.
Greater Manchester Combined Authority (Manchester)
1 year 5 months
2016-04 - 2017-08

Remote and onsite operations support

ICT Engineer
ICT Engineer
  • Remote and onsite operations support for staff numbering 3500 across all council sites.
  • Administration/support of Citrix user profiles through Citrix Director (shadowing and resetting).
  • Enterprise application support for Citrix Director, FortiClient VPN, Clearswift and Egress Switch.
  • Manage on-boarding, retirement/decommissioning and relocation of equipment.
  • Image deployment of Windows 10 operating system and software using SCCM 2012.
  • Applying project management principles to monitor and control system deployments.
  • Supporting and repair of PCs, laptops and tablets (Dell, HP and Microsoft) on wireless/VPN.
  • Created and maintained users, groups and computer accounts in Active Directory.
  • Liaising with 3rd party support to investigate, diagnose network, hardware and software problems. 
Barnsley Metropolitan Borough Council (Barnsley)
1 year 5 months
2014-12 - 2016-04

Requirements gathering/scoping, end-to-end testing

Clinical Systems Administrator
Clinical Systems Administrator
  • Technical lead and support of departmental Diagnostic Genetics I.T. applications/infrastructure for 120 staff.
  • Requirements gathering/scoping, end-to-end testing, implementation and sign off for Next Generation Sequencing, New Born Screening and GeneMapper projects.
  • Facilitated workshop for New Born Screening project, to show stakeholders interface and design layout of new system.
  • Attendance of multi-disciplinary team meetings with Informatics team leads.
  • Support of laboratory equipment (including SATO barcode scanners & label printers / FluidX barcode readers) and associated software. Training laboratory staff on use of equipment.
  • Application installation/implementation, configuration and management of departmental clinical/ genetics systems including STARLIMS (web servers/interfaces and underlying SQL databases),
  • Managing and supporting vendors during site visits.
  • Implementation of md5 checksums to verify data integrity for data transfers.
  • Administration, monitoring and backup of departmental servers.
  • Implemented change and release management controls to plan for system outages while updating servers and releasing new versions of software, communicating changes to system users.
  • Built Lenovo RD650 servers, installing Linux Ubuntu for New Born Screening and NGS projects.
  • Maintenance and management of HP Proliant Gen 6-8 server hardware.
  • Applying project management principles to monitor and control Windows 7 rollout.
Sheffield Children?s Hospital NHS Foundation Trust / Sheffield Diagnostic Genetics Service (Sheffield)

Aus- und Weiterbildung

Aus- und Weiterbildung

  • BSc (Hons) Computing (2:1): University of Central Lancashire
  • Futures Gold Award: University of Central Lancashire
  • Computing (Diploma of Higher Education): Manchester Metropolitan University
  • GNVQ Advanced Information Technology (Distinction)
  • GCSE Mathematics (B), English Language (B) Information Systems (B)


PROFESSIONAL TRAINING CERTIFICATES

  • IASSC: Lean Six Sigma Green Belt - Currently Pursuing
  • ITIL: IT Service Management ? Foundation (Self Study)
  • PRINCE2: Project Management ? Foundation (Self Study)
  • STARLIMS (Configuration Course): Pass (STARLIMS / Abbott Informatics Europe Ltd)
  • NVQ Level II: Customer Service (Derby College)
  • NVQ Level II: Information Technology (Link Training)

Kompetenzen

Kompetenzen

Top-Skills

Computer System Validation (CSV) Engineer GxP Compliance GMP LIMS Project Management Project Delivery Vendor Management Stakeholder Management TrackWise Veeva Sample Manager Deviation and CAPA Management Change Control Management Systems Implementation Backup Management System Restoration

Produkte / Standards / Erfahrungen / Methoden

PROFILE

Accomplished Validation/CSV Engineer with a proven track record in successful validation and qualification of diverse laboratory systems and equipment. Key strengths include: applying strong technical knowledge to ensure successful project delivery, engaging with key stakeholders to deliver high performance cost effective solutions. Demonstrated expertise in project management and driving process improvements to optimise laboratory operations. Committed to fostering a culture of compliance and continuous improvement. Harnessing a strong business awareness to ensure System solutions align with organisational strategy and deliver the expected customer benefits. Seeking to leverage extensive experience and technical proficiency in a Senior Validation/CSV Engineer role at a dynamic organisation focused on innovation and excellence in the pharmaceutical and biotechnology sectors. 


KEY SKILLS

  • Computer Systems Validation
  • Vendor Management
  • Stakeholder Management
  • Deviation and CAPA Management 
  • Change Control Management 
  • Regulatory Compliance / Data Integrity
  • Project Management and Delivery
  • System Implementations
  • Backup Management, reporting and recovery 
  • System Restoration 


CAREER HIGHLIGHTS

  • Successfully assisted in the qualification of the upgraded SampleManager LIMS 21.0 system, ensuring its efficient implementation and site-wide utilisation at Alkermes Athlone.
  • Qualification of SCIEX PA 800 plus Capillary Electrophoresis (CE), Charles River ELx808 BioTek Microplate Reader & Endosafe nextgen-PTS and BioMérieux BACT/ALERT systems in the QC laboratories at MSD Dublin. Execution of IOQ protocols for and reports for CTUs (Fridges, Freezers and Incubators) for qualification in the QC laboratories in Dublin. 
  • Proficiently validated DataAnalyst (supporting software package for Lasair III particle counters), SPECTRAmax 190 Microplate Reader, Sievers M9 TOC Analyser and Dionex ICS-5000 systems in the QC laboratories at Alexion Dublin. 
  • Successfully managed projects involving the installation and configuration of Lenovo RD650 servers with Linux Ubuntu, for NGS (Next Generation Sequencing) and New Born Screening projects at Sheffield Diagnostic Genetics Service. Contributed to increasing departmental budget by 25%.
  • Implementation of new server hardware for Next Generation Sequencing and New Born Screening projects, installation of new GeneMapper application software and data migration at Sheffield Diagnostic Genetics Service. Achieved improved user experiences and business outcomes through seamless system enhancements. 

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