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Validation Manager Resume Samples
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6-10 years of experience
Effectively managed a team of analysts responsible for processing monthly loss data from both internal and external third party administrators.
- Ensured 100% accuracy in data prior to acceptance to the AIG corporate ledger through downstream billing, booking, cash reimbursement and regulatory reporting.
- Maintained frequent communication with internal and external stakeholders, including third party administrators, brokers, those insured and outside vendors to build rapport, resolve account issues and address business needs.
- Successfully developed multiple system enhancements, in addition to performing UAT and signoff.
- Accountable for the processing and acceptance of $6B in annual loss data from 60+ third party administrators into AIG’s claim processing system.
- Achieved and maintained a monthly data quality error rate of less than 1% by utilizing strong account management and third party administrator communication abilities.
- Developed, performed UAT and implemented an automated Monthly Error Tracking dashboard report to monitor both the accuracy and timeliness of third party administrator data corrections.
0-5 years of experience
Leveraging a team of 7 direct reports, managed the Merck Rahway Site annual and long range capital Plan. Managed engineering departments financials including: expense forecasts, capital approvals / spending, depreciation forecasts and site abandonments.
- Controlled departmental budgets resulting in $340M favorability against profit plan.
- Created a cost tracking database reducing monthly manual effort by 70%.
- Authored and enforced site depreciation policy resulting in an increase in near term depreciation forecasting from +/- 25 % to +/- 8% within 2 quarters.
- Reduced invoice exceptions backlog from $15MM (2 year) to $0 (0 months). Eliminated annual freight charge exceptions by 85%.
6-10 years of experience
Designed and coordinated the incorporation of global systems to enhance Product Lifecycle Management, including document management system (DMS), SAP change management, and bill of materials program. Devised and governed systems and personnel to ensure responsibilities were performed utilizing efficient business processes, while maintaining corporate policies and regulations.
- Designed and implemented a single point of reference for the marriage of a product’s formula to its respective package, by integrating shared service center personnel and business processes
- Increased accountability and decreased complexity by revising and applying a global production trial process
- Assured compliance with ISO guidelines for 9001, 14001 and OHSAS 18001 through training, auditing and implementation of an integrated management system
- Reduced turn-around time from an average of 15 days to less than 3 days via revising the Nonconformance and Corrective Action and Preventive Action system
- Reduced financial overhead by 40% by streamlining business processes
0-5 years of experience
Responsible for the assessment, then management and completion of life cycle (SLC) documentation required for an ISO 9000 CRO’s computerized system adherence to regulations concerning validation, 21 CFR Part 11 & ISO 9000 compliance. Conducted a gap-analysis of validation policies and procedures and updated all to meet industry standards and best practices. This effort included:
- Authored a company-wide “computerized system validation” policy letter in support of QMS.
- Streamlined procedures via new three (3) SOPs – an SOP for validation requirements, an SOP for in-house developed systems and an SOP for project systems.
- Introduced new tools for 21 CFR Part 11, validation determination, and risk-based assessments. Created a summary report for auditors to review.
- Added GAMP 1-5 categorization, defined how IQ, OQ and PQ fit into the SLC process, introduced SLC risk analysis, and added a retirement phase.
- Created new templates for 20+ supporting validation documents and forms.
- Managed several validation efforts to include in-house developed systems as well as COTS.
0-5 years of experience
Responsible for all aspects of qualification and validation associated with a Phase 3, BL2 Clinical Vaccine Manufacturing Facility.
- Established and implemented a Risk Based Validation Program including a Facility Validation Master Plan, 21 CFR Part 11 Assessment & Remediation Policy, Periodic Validation Review / Revalidation SOP for Equipment, Utilities, QC Laboratory, and Computerized Systems.
- Managed the installation, commissioning, startup and qualification of a Barrier Isolator serving a high speed vial fill line. Effort included VHP decontamination validation.
- Reviewed and approved all qualification & validation project plans, protocols, project plans and final reports.
- Evaluated change control submissions for validation impact as a member of the Change Control Committee.
- Prepared overall validation summary for BLA submission to FDA.
0-5 years of experience
Responsible for performing computer system and software validation of applications used in a medical device manufacturing environment.
- Performed validations of new and existing software applications, computerized systems and related database applications using a risk-based approach. Software included both off-the-shelf and in-house developed applications.
- Insured compliance with 21 CFR Part 11 and predicate rules under 21 CFR Part 820.
- Developed all validation related documentation (plans/procedures) and wrote validation tests.
- Managed internal and contract personnel in local and remote locations.
- Provided project estimates and timely completion dates as well as regular project status updates to team members and internal customers.
- Completed Six Sigma projects in order to reduce cost and increase efficiency.
- Validated company-wide implementation of ERP system.
0-5 years of experience
Developed and implemented the cleaning validation program utilizing a risk-based approach.
- Managed and mentored permanent staff of four Validation Specialists, augmented with contractors as needed.
- Led Validation Review Board, where validation strategy and requirements on cleaning, process, equipment, and software systems were agreed upon with Operations, R&D, Laboratory Operations and Quality Assurance.
- Prioritized and managed qualification and validation projects meeting the expected timelines. Reviewed and approved all associated documentation.
- Effective communication with customers, multi-disciplinary project team and upper management.
- Authored and executed engineering studies and validations as needed. Trained Validation, Laboratory and Operation Staff on protocol, batch records, and testing procedures.
- Developed and implemented SOPs and templates governing equipment, process and cleaning validation, change control and technology transfers. Trained Division and Site QA and Operations on updated documents.
- Performed impact assessments for change control documentation.
0-5 years of experience
- Managed a team of Cash Validation Analysts reviewing and validating monthly servicer payments using approved and auditable processes for the Department of the Treasury’s HAMP program.
- Subject matter expert on validation and cash issues and system development for improvements.
- Validated $100,000,000+ of monthly payments with 4-6 day timeframes, identified and resolved compensation accrual and disbursement exceptions for loan modifications. Identified and documented root cause of exceptions for Treasury.
- Consistently met service level agreements of on-time, accurate deliveries of results while observing strict compliance regulations for validated data.
- Developed process and procedures for streamlined validations in using both automatic and manual processes.
- Developed system requirements for increased automation of existing manual processes and improving existing automation to cash validation and analysis routines.
0-5 years of experience
Managed validation and testing activities in 2 facilities including a Multi Product Cell Culture and Protein Purification Facility plus an existing Fermentation Facility (including process validation).
- Managed the commissioning and qualification of a newly constructed $50 MM Multi Product Cell Culture And Protein Purification Facility including the following:
- Managed 4 direct reports, 8 consultants, and 3 5 indirect reports.
- Established compliance and validation methodologies and policies
0-5 years of experience
Wrote validation master plans and established validation and engineering quality systems.
- Wrote SOPs including: writing and executing validation IQ, OQ and PQ protocols, writing validation final reports, reviewing executed validation protocols (IQ, OQ, PQ) and final reports, revalidation program (annual/biannual revalidation of autoclaves, temperature mapping of thermal units).
- Supported product/technology transfer processes, including evaluation of raw materials and components.
- Supported technical troubleshooting process in the manufacturing environment.
- Supervisory and Budgetary responsibilities included recruiting, hiring and managing validation staff and managing and executing yearly budget.
- Reviewed CMO validation protocols (IQ, OQ, PQ; cleaning and sterilization, where applicable); autoclaves, Wave bioreactors (50L and 200L), fixed tank bioreactors (1000L), columns, pumps, mixers (disposable bags), cleaning validation, sterilization validation, manufacturing SOPs and quality systems.
- Developed validation training modules and conducted training sessions.
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Validation Manager
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
