SUMMARY

• Senior Validation Engineer and project manager with over 30 years’ 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 within 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 within all areas of labs, facilities and manufacturing.
• Performed numerous internal and external audits concerning Pharmacovigilance for US and International isubsidiaries ensuring compliance with 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 with 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.
• 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 within time constraints and under budget.
• Diverse skill-set encompassing every role within 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 with PrinCE Microinjector, iCE280, Hyperion, Royco, Corning, Fisher Scientific, Mettler-Toledo, DCS20, TC15, STARe, Waters HPLC, Thermo Spectronic, Thermo Electron, Labconco, Crescent HPLC, HBLT, 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, 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, 21CFR 111, 21CFR 820, 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, IEEE828-830, 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, 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, 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

Sr Computerized System Validation Engineer

Responsibilities:

• 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 data collection.
• 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 laboratory samples measuring Endotoxins, potency, pH, sterility and visual purity.
• Performed qualification of clean rooms, incubators, freezers and compounding pumps and hoods, as well as CAPA responses.
• 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 RSLogix ladder 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.