SUMMARY

• Senior Validation Engineer and project manager wif over 20years experience in the programming, qualification, commissioning, qualification, auditing, validation, disaster recovery/business continuity, gap assessment and remediation of laboratories, pharmacovigilance, automated processing, manufacturing, packaging, labeling, laboratory, clinical, distribution and drug safety systems wifin regulatory environments of pharmaceutical, medical device and biopharmaceutical industries.
• Trained by the FDA as an Auditor on 21CFR11 and Pharmacovigilance areas of compliance. Performed as an FDA Auditor for inspections and audits of pharmaceutical companies in the US, Netherland, Ireland, UK and Germany.
• Experienced in assessment and remediation of Part 11 compliance wifin all areas of labs, facilities and manufacturing.
• Performed numerous internal and external audits concerning Pharmacovigilance for US and International isubsidiaries ensuring compliance wif both FDA and EU regulations.
• Performed commissioning of laboratories, validation of lab equipment and LIMS data collection installation and validation.
• Expert in the full validation lifecycle of FDA regulatory systems including computers, PLCs, manufacturing, laboratory, packaging, labeling (creation and validation), serialization, warehousing (including distribution, clinical and Pharmacovigilance areas. Includes creation, review and approval of protocols and procedures to ensure compliance wif QSR, QMS, GLP, GMP, GPvP, GCP, GXP and other FDA, MHRA, ISO and GAMP regulations.
• Experienced in validation, development, change control and programming of process automation control systems used JIRA and has worked in HP - ALM environment.
• Experienced in the review and remediation of full SDLC validation lifecycle documents for client/server, ERP (Oracle and SAP), stand-alone and mainframe systems utilized in the areas of manufacturing, warehousing, drug safety, clinical &labs.
• Superior interpersonal skills that ensure delivery of fully validated and compliant systems through the emphasis on a team environment approach, ensuring delivery of protocols and procedures wifin time constraints and under budget.
• Diverse skill-set encompassing every role wifin the complete lifecycle of both SW/HW systems.

TECHNICAL SKILLS

PLC’s / Automation Systems: Allen-Bradley, Fisher, Foxboro, Emerson, DELTAV, FactoryTalk, Data Historian (SE and ME), Siemens InfoCenter1.6.5, Siemens Insight 3.1.2

Lab Equipment: ABI, Agilent 2100 Bioanalyzer, Biomek NXP Bioassay robotic workstation, Beckman / Coulter, Cole-Parmer, Convergent iCE280 Analyzer wif PrinCE Microinjector, iCE280, Hyperion, Royco, Corning, Fisher Scientific, Mettler-Toledo, DCS20, TC15, STARe, Waters HPLC, Thermo Spectronic, Thermo Electron, Labconco, Crescent HPLC, HBLT, FTIR, Applied Biosystems Real-Time PCR, NICOLET Avatar, Perkins-Elmer, Forma-Fisher freezers, Perkins-Elmer Atomic Absorption Spectrometer, Instron, Labware LIMS, Brinkmann Tuttnauer autoclave, Nautilus LIMS, Waters Nugenesis LIMS, Cognition Cockpit, SampleManager

Manufacturing / Packaging Equipment: Pneumatic heat sealers, Tablet fillers, Powder fillers, Thermoformers, IPC injection molders, PPE manufacturing, scan-code inkjet printers, Heidelberg offset printing presses, Tyvek sealing, granulators, label printers, serialization, EFD glue dispensers, heat guns, case sealers, driers, external coating machines, burst testers, ovens, water baths, freezers, heat exchangers

Standards/Methodologies: FDA, cGMP, cGLP, cGCP, cGXP, cPvP, 21 CFR 11, 21 CFR 58, 21 CFR 210, 21 CFR 211, 21CFR111, 21CFR820, 21 CFR 4a, 21 CFR 201, 21 CFR 314, and 21 CFR 601, ASTM E2500, MDD 93/42/EEC, ICH, ASME, ASTM, ISPE, ISO900x, ISO3270, ISO13485, ISO14971, IEC 62304, CE Marking, MDD 93/42/ECC, GAMP4/5, ISEE, Mil Std 2167a, DoD, SOX, HIPAA, EMEA, eIND, IEEE, 1012, 1016, 1028, 1074, ALCOA, RUP, RAD, CMM, SDLC.

Platforms: MVS, VM, VM/SE, VM/SP, VAX, DOS, Windows 3.5/95/98/NT/2000, OS/2, AS400, Sun Solaris, BEA Systems, UNIX, AIX, MAC, CP/M, HP1000, HP2000,HP-ALM Macintosh, DATASYM, Apple, Oracle, VMware

ERP: SAP R/3 R4 (MM, PP), Oracle 11i (BOM, WIP, ENG, PO, INV, DM, QM, PM, etc.)

Databases: Sybase, Dbase. DB2, Oracle, SAP, MS SQL Server, (also w/ SQL, SQL/DS, etc), Oracle R12

Hardware: IBMxx (most all mainframes and mid-frames), CISCO, SUN SOLARIS, SUN OS, Apple, Macintosh, CRAY, Kodak, Ericsson, Motorola, Lucent, NTI, AS400, Sharp, TEC, MICROS, PS/2, SWEDA, TOSHIBA, Dell, HP

Applications: Project, Word, Visio, Excel (w/macros), Access, Reflections, FactoryTalk, Rs Powerpoint, Expressions, Outlook, Project, Publisher, Documentum,TrackWise,NetMechanics, Interdev, ASP, FrontPage, HP Quality Center,HP-ALM, VBScript, SiteLoad, Remedy, WinRunner, LoadRunner, QA Partner, Rational Test Suite, Test Director, File-AID, TCP/IP, RACF, WYLBUR, JCL, TSO, ISPF, CP, CMS, E, PE2, File-Aid, PVCS, CMM, VB, VM/SP, HTML, SGML, SCRIPT/VS, GML, ISIL, CGI, SS, SRS, IRS, PIS, GroupWise, Reflections, SQL, OfficeVision, Lotus Notes, PageMaker, PIPELINES, APPC-LINK, CorelDraw, FreeLance, PITS, RETAIN, HONE

PROFESSIONAL EXPERIENCE

Confidential, Philadelphia, PA

Data Integrity Validation Engineer

Responsibilities:

• Performed gap assessment for data integrity and parameter limits for the Glove Integrity tester and Meco Clean Steam Generator.
• Remediated data integrity wif validation and SAT for a Glove Integrity tester and used JIRA.
• Remediateddata integrity wif validation and IOQ validation of a Meco Clean Steam generator.
• Updated SOP’s to ensure full coverage of data integrity policies and GMP compliance

Confidential

Sr Computerized System Validation Engineer

Responsibilities:

• After gap assessment, developed remediation plan, halped develop SOP’s and remediation testing and validation to fill gaps.
• Performed qualifications on MasterControl process modules for reporting, document management, audit management and BOM.
• Validated the Blue Mountain Regulatory Asset Manager (RAM) software for customized asset management and calibration.Performed data integrity analysis(ALCOA) between FactoryTalk Data Historian and Lyophilization PLC’s.
• Performed qualifications on OSIsoft PI system for data management and reporting.

Confidential, Lake Forest, Illinois

Sr Validation Engineer, Analytical Laboratory Validation Engineer

Responsibilities:

• After certified training in Data Configuration of ThermoFisher SampleManager LIMS, developed user and functional requirements and wrote validation protocols for compounding laboratorysamples measuring Endotoxins, potency, pH, sterility and visual purity.
• Performed gap assessment, remediation and qualifications of clean rooms, incubators, freezers and compounding pumps.
• After risk assessment and analysis, performed process validation of ASC and PULSE software updates and wrote the PPQ that verified the compounding of narcotics into bags and syringes, through to the labeling, packing and shipping of product.
• Performed data integrity between RSLogixladder logic, incoming data from PLC’s and FactoryTalk Data Historian.
• Developed rationale in responses for 483’s and worked to plan and mitigate these deficiencies.

Confidential, Chicago, Illinois

Building Automation Validation Engineer

Responsibilities:

• Upon gap assessment, developed a remediation plan and wrote IOPQ for the Siemens Building Automation/Management System (BAS, BMS) for clean suites containing biosimilar laboratories, manufacturing, packaging, and warehouse suites.
• Performed validation and data integrity ofthe BAS/BMS for clean suites containing laboratories, manufacturing, packaging, and warehouse suites. Pressure, Humidity and Temperature sensors were qualified, as well as Differential Pressure.Ensured all servers and backup serversmet IOPQ to required specifications. HP QC was used in reporting and in qualification trending.