Professional Summary
Strategic, results-driven operations professional offering expertise in
supporting regulated GxP environments, validating software with GAMP 5,
21 CFR Part 11, Annex 11, and ICH guidelines, testing change control
management, and implementing business applications.
Innovative business partner, effective communicator, and problem-solving
project manager known for building strong partnerships with QA, IT, and
engineering teams to assess risk, create and implement validation plans,
perform IQ, OQ, and PQ testing for instrument software across major
brands, including Agilent, Waters, Thermo Fisher, and SaaS systems.
Collaborative leader and resourceful team contributor with demonstrated
success in validating manufacturing technologies, software applications,
and laboratory systems; ensuring audit readiness; preparing periodic
review and validation summary reports; and supporting critical business
initiatives.
Experience
Experienced in developing, updating, reviewing, and approving qualification
test protocols (IQ, OQ, PQ) and data migration protocols in alignment with
the Software Development Life Cycle (SDLC). Proven expertise in managing
the validation lifecycle for laboratory and enterprise systems, including
MasterControl QMS and MES Electronic Batch Record (EBR), ensuring
compliance with 21 CFR Part 11 and GAMP 5.
- Develop, update, and maintain validation test protocols, including IQ, OQ, and PQ, and data migration protocols for AKTA Unicorn and Vicell XR software, ensuring full alignment with SDLC.
- Manage the configuration and validation of MasterControl modules and MES EBR systems, executing Change Controls to support software updates, patches, and version upgrades while maintaining the validated state.
- Author and execute User Requirement Specifications (URS) and Functional Risk Assessments (FRA) for new software implementations, ensuring all business and regulatory requirements are met before purchase and installation.
- Serve as the CSV Subject Matter Expert (SME) during internal and external audits (FDA/ISO), defending validation packages, data integrity controls, and investigation reports for GxP systems.
- Enforce Data Integrity compliance by performing periodic system reviews, user access administration, and audit trail verification to ensure secure and attributable data management.
- Collaborate on document change controls, system change controls, and deliverables.
- Lead validation of data migration activities during system upgrades, verifying accurate transfer of critical GxP data between legacy and new platforms.
- Author and review SOPs for system operation, backup/restore, and disaster recovery so procedures reflect current validated configurations.
- Investigate and resolve software-related deviations and non-conformances through root cause analysis and CAPA actions.
Develop, update, review, approve, and maintain qualification test protocols,
including IQ, OQ, and PQ, and data migration protocols in alignment with
SDLC.
- Partner with internal and external IT teams, business owners, and system owners, developing requirements specifications including URS, FRS, and SDS for GxP systems.
- Develop and maintain Master Validation Plans (MVPs), Validation Plans, and data migration plans for e-systems.
- Devise, update, review, approve, and maintain summary reports and requirement traceability matrices.
- Review planned and unplanned changes, including configuration updates, system enhancements, operating system updates, and application updates, and assess validation impact.
- Perform risk assessment of proposed changes to determine scope of validation or re-validation.
- Own and execute change control tasks related to system validations.
- Develop, maintain, and execute e-system periodic review plans to ensure validated electronic systems remain in compliance with IT and Quality procedures, including change control, backup, recovery, and access control.
- Refine CSV policies and procedures by conducting independent evaluations of existing documentation.
- Participate in vendor audits to ensure systems used by GxP vendors meet FDA regulations and industry validation standards.
- Collaborate on document change controls, system change controls, and deliverables.
- Coordinate with the Training and Document Control Department to manage document change controls and documentation in Veeva Vault.
- Author validation deliverables, including User and Function Requirements (UFRS / URS / FDS), Traceability Matrices, and Validation Summary Reports using Kneat and Valkit.ai.
- Execute validation protocols.
- Coordinate with site IT and QC teams for qualification and CSV validation activities.
- Review audit trails for all systems during periodic reviews of GxP systems.
- Collaborate with the sales team to update Statements of Work (SOWs) for customers.
- Review and create change controls and deviations based on incidents.
- Create SOP and work instruction documents for systems.
- Execute troubleshooting with technical teams for software issues.
- Lead validation strategy and delivery for Agilent OpenLab deployments across five customer sites, ensuring full GAMP 5 compliance and audit readiness.
- Manage and track validation tasks, deviations, and change controls through JIRA, maintaining lifecycle traceability and status visibility.
- Maintain validation documentation, SOPs, and decision logs in Confluence and link them to JIRA for execution and audit readiness.
- Conduct risk assessments to determine validation rigor based on system impact and complexity.
- Implement CSA principles to streamline validation of low-risk systems while maintaining compliance.
Developed Computer System Validation deliverables in compliance with
21 CFR Part 11, GxP, GLP, and GMP regulatory requirements.
- Developed IQ, OQ, PQ / OPQ for systems including Agilent MassHunter, Thermo Fisher Qtegra (ICPMS / ICPOES), Waters MassLynx, PharmSpec, LCMS, Perkin Elmer FTIR, UV iTeva, Proveris Spraytech, Sprayview, Viota, Malvern 2000, Malvern 3000, and Shimadzu UV software packages.
- Validated NuGenesis SDMS and ValGenesis environments for all servers and clients.
- Wrote validation protocols for computerized laboratory systems for 21 CFR Part 11 compliance.
- Created documents including User and Function Requirements (URFS / URS / FDS), Traceability Matrices, and Validation Summary Reports for validation deliverables.
- Authored administrative SOPs for data backup procedures and laboratory software.
- Performed daily monitoring of backup and troubleshooting of cold backups, hot backups, and Avamar servers.
- Troubleshot virtual GMP environments with Analytical and Research / Quality Control departments.
- Deployed, administered, troubleshot, and upgraded physical and virtual servers for multiple sites.
- Performed administrative and validation tasks for the ValGenesis validation tool.
- Implemented master data changes within ValGenesis, streamlining compliance processes and reducing data errors while aligning with regulatory and specification requirements.
- Led template management across Amneal sites, including uploads, content-type binding, and version revisions.
- Partnered with cross-functional teams to ensure smooth execution of data and template updates for better efficiency and audit readiness.
Integrated third-party applications and services into laboratory environments,
leveraging strong qualification and validation expertise.
- Administered, troubleshot, and upgraded physical and virtual GMP servers for several lab sites.
- Supported and maintained laboratory applications, computers, and servers used in lab environments.
- Analyzed, identified, and implemented enhancements, upgrades, and solutions to improve desktop platform support efficiency.
- Troubleshot client instrument workstations, applications, and IT issues throughout the lab.
- Developed, documented, and conducted periodic inventories of client systems, sharing deep OS, desktop hardware, and peripheral knowledge.
- Managed GMP Avamar servers and troubleshot backup failures.
- Managed GMP vSphere and GMP vCenter, and resolved vMotion storage issues by creating new VMs.
- Managed ServiceDesk ticketing system.
Built, installed, and managed physical and virtual server environments and
maintained documents within controlled systems.
- Documented, monitored, and audited physical and virtual server environments.
- Troubleshot Cisco routers and switches, including VLAN and routing issues.
- Managed user accounts for GMP laboratory systems and office networks.
- Created and named Waters Empower projects within laboratory environments.
- Maintained backups and VM environments for GMP isolated and office networks.
- Monitored system performance, server activity, and server logs.
- Created and maintained documentation related to system configurations and IT assets.
- Collaborated with manufacturing teams for software including AKTA / JASCO and maintenance activities.
- Provided lab and production support in GMP environments.
- Performed supplemental network and system administration support for the IT team.
- Built and maintained high-availability servers, storage, and networks, including Dell / HP servers and EMC VNX storage.
Monitored daily health of hardware, software, storage, and network systems,
including performance, email flow, server activity, logs, access and audit
logs, and backup logs.
- Created VDI and maximized system uptime, security, and performance by directly addressing and reporting concerns to Infrastructure leadership.
- Performed daily maintenance routines for backups, logs, and storage and partnered with EMC teams for backup issues.
- Installed operating system software, patches, upgrades, and application software.
- Conducted server builds and system implementations for assigned infrastructure projects.
- Provided Tier 3 troubleshooting support.
- Maintained status reports for infrastructure changes and projects.