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SynopsisBS Chemical Engineer with 20+ years of Engineering & Project Management experience in Commissioning, Validating and Verifying (V&V) the Compliance to FDA & Client Corporate Requirements for Pharmaceutical API (Active Pharmaceutical Ingredient), Aseptic, Liquid, Gel & Oral Solid Dosage (OSD), Pediatric Vaccines, Blood Fractionation (21 CFR 210 & 211), Medical Device (21 CFR 820) Facilities, CGXP, GAMP5, Computer Systems (21 CFR Part 11), Data Accuracy and Integrity, ALCOA and ALCOA+ including PLC and SCADA applications, Environmental, Safety OSHA (29CFR 1910.120) and Industrial Environmental Remediation, Quality System ISO13485, 21CFR part 820 and current regulatory standards.Combined Chemical Engineering principles, industrial/pharmaceutical plant and computer control experience to develop approve, execute & verify multiple equipment/systems compliance including Commissioning and Remediation, IQ/OQ/PQ protocols, Process Verification (PV), Requirements Traceability Matrices (RTMs) and Failure Mode and Effects Analysis (FMEA) and equipment/systems GAP analysis needed to verify compliance with corporate and government requirements.Developed/executed/reviewed/approved documents for Computer Control Systems (PC, Allen-Bradley PLC, Distributed Control Systems (DCS), Supervisory Control and Data Acquisition (SCADA) and DeltaV) and Computer Software Validation (CSV) and Testing.Evaluated new & legacy equipment/systems for 21 CFR Part 11, ALCOA compliance, developed documentation to meet requirements as needed.Reviewed/approved V&V documents: Master and Equipment/System Validation Plans & Reports (VMP, SVP and VMR), Design Specifications (DS), Functional Specifications (FS) and User Requirement Specifications (URS) to verify corporate Quality Control (QC), Quality Assurance (QA), Change Control and FDA requirements were met including cGMP and GDP. Developed and participated in equipment Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).Performed equipment/system Commissioning/Startup including walk-downs, Process & Instrumentation Diagrams (P&ID) review, Process Flow Diagrams (PFD), Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Developed, wrote, reviewed, and approved Standard Operating Procedures (SOP).Trained personnel in SOP & protocol writing, execution, proper discrepancies documentation and Corrective Action Preventative Actions (CAPAs) including client and regulatory Good Documentation Practices (GDPs) and ALCOA+, classified area gowning requirements for access.Coordinated with QA, QC, Engineering, Maintenance, Safety and Metrology departments.Safety Training: OSHA 40 Hour Hazwoper OSHA 29 CFR 1910.120 & 1926.65.Experience:Jun. 2023  July 2023, Livent, Bessemer City, NC, Equipment/System Validation RemediationEquipment and system remediation used in lithium chloride production.Mar. 2022  Aug. 2022, Thermo Fisher Scientific (CMO), Greenville, NC, QA Validation ConsultantCreated System Design Specification (SDS) documents for newly installed sterile vial and syringe inspection & packaging equipment for AVI (Automated Visual Inspection), final inspection and packaging.Vial processing included Optima automated vial washing, Wilcomat leak detection, Seidenader automated inspection, Dabrico visual inspection and Optima labeling.Syringe processing included Seidenader automated inspection, labeling and final packaging.Both processing lines were fed to Dividella packaging equipment, Pester final packaging equipment and recorded/verified using a Systec serialization system.Nov. 2021  Dec. 2021, Charles River Laboratories, Memphis, TN, Validation ConsultantReview and update of new and existing system validation documents.Provided sterile fill lines support, review and approval of qualification documents.July 2021  Oct. 2021, Hosokawa Micro Powder, Summit, NJ, Validation ConsultantReview and update for new system validation documents.Mar. 2021  May 2021, Thermo Fisher Scientific (CMO), Greenville, NC, QA Validation ConsultantProvided on-site capital projects support for the installation of new sterile fill lines and additional quality support for review and approval of qualification documents.Responsible for review and approval of validation documents, including design qualification, commissioning, and review of IQ, OQ, PQ and other validation documents.Sep. 2019  Nov. 2019, AKORN Pharmaceuticals, Vernon Hills, IL, Quality AnalystWrote/executed laboratory instruments test for 21 CFR Part 11 & ALCOA+ compliant.Instruments included:TA Instruments DSC 250 Differential Scanning Calorimeter with TRIOS/Guardian Software.Mastersizer 3000 particle size analyzer, Agilent 780 Dissolution Apparatus and 850 Sampler.Sep. 2018  Mar. 2019, Merck (Vaccine), Durham, NC, Automation Quality ConsultantAutomation Software Development Life Cycle (SDLC), document Quality Reviewer/Approver documents including Requirements and Configuration Specifications, Test Plans, RTMs, Change Controls including incident and deviation management.Provided CSV activity oversight for compliance with corporate procedures, industry standards, FDA regulations/guidance, GAMP documents and SDLC validation.Jan. 2018 - Aug. 2018, Astra Zeneca, Shepherdsville, KY, Validation EngineerResponsible for validation and document management to meet GMP/GDP compliance for the collection, storage, and shipping of flu vaccines. Supported operations. and investigations.Wrote validation protocols/reports & maintained site validation procedures. Provided GAP support and remediation for ERES and 21 CFR Part 11 requirements. Maintained liaisons with external suppliers for computer systems updates/modifications.Dec. 2016  Sep. 2017, LONZA (Media Production), Walkersville, MD, Senior CSV ConsultantModified existing DeltaV system controlling media production, FDA 21 CFR Part 11, mixing and cleaning studies to verify the media production and dispensing equipment. Met classified areas gowning requirements.Participated in qualification of the Organ Recovery System (ORS) media.Qualified in-process laboratory equipment.Jun. 2016  Nov. 2016, VistaPharm (Liquid Process), Largo, FL, Sr. Validation ConsultantEvaluation and remediation of installed process equipment and qualification of new equipment and associated facilities and utilities to meet FDA and Corporate requirements. Met gowning requirements for access to classified areas.Apr. 2016  May 2016, PAI (Liquid Process), Greenville, SC, Validation ConsultantWrote new equipment qualification protocols (IOQ).Sep. 2015 - Feb. 2016, BioTest (Blood Plasma), Boca Raton, FL, Sr. Validation ConsultantWrote cleaning validation protocols for Fractionation & Purification Equipment and components.Performed risk assessments to define CIP cycle parameters and mitigation activities to reduce risk. Met gowning requirements for access to classified areas.Apr. 2015 - Sep. 2015, GlaxoSmithKline (Solid Dosage), Aiken, SC, Sr. Compliance ConsultantThe authored/executed IQ, OQ & PQ equipment qualifications for a new solid dosage suite and the associated facilities and utilities. Presses included Korsch XL-400 & XL-800 and support equipment. Met classified areas gowning requirements.Feb. 2015 - Mar. 2015, Mallinckrodt Pharm (Solid Dosage), St. Louis, MO, Sr. Val. EngineerReview and execution protocols for Building 260 Expansion. Included slurry pumps, glycol heat exchangers and BHS Sonthofen Model BF050-045 vacuum belt filter for oxycodone production.Jun. 2014  Dec. 2014, DePuy Synthes (Med Device), West Chester, PA, Sr. ConsultantLegacy review for the Global Remediation Quality Plan (GRQP) to determine the risk levels for existing US and EU facilities water systems and provide remediation guidance.Mar. 2014  Apr. 2014, Catalent Pharma (Solid Dosage), Kansas City, MO, Sr. ConsultantPerformed reviews of SOPs and qualification documents for solid dosage packaging equipment.Oct. 2011  Dec. 2013, SANDOZ (Solid Dosage), Wilson, NC Sr. Compliance ConsultantPerformed risk assessments, document qualification review, FMEAs and remediation needed for equipment. Included: blenders, Zanchetta tumblers; Vector and Gral granulators; Glatt, Vector and Nitro fluid bed dryers; Fitzmills, Chilsonators, ovens, Bosch encapsulators, Fette tablet presses, O'Hara tablet coaters, and packaging equipment.Wrote and performed qualifications and SOPs for: Mettler-Toledo Safeline metal detector, Sani-Matic Parts Washer including cleaning studies.Wrote the SOP for AQUA-BLEND SNG (Synthetic Natural Gas) Venturi Blending System.Performed Kaye Validator temperature mapping studies for existing drying ovens.Met classified areas gowning requirements.Aug. 2011  Sep. 2011, Amylin (Bio-Pharm), West Chester, OH, Sr. Compliance ConsultantCSV Protocol discrepancy review and resolution for the Bydureon product line control system.Feb. 2011  Aug. 2011, Millipore (Pharm. Filter Manuf.), Jaffrey, NH, Sr. Equipment EngineerEvaluated operation of Millipore Graded Failure 4 Allen-Bradley automated test equipment for the Millipore Physical Testing Laboratory to confirm the equipment met the URS.Sep. 2010  Feb. 2011, Patheon (Solid Dosage), Cincinnati, OH, Validation ConsultantEvaluated production, packaging/process equipment, wrote/executed qualification protocols and SOPs. Included PLC CSV and computer-related systems/process equipment; system specifications preparation & qualification test; SOP development, process control diagrams and final reports. Met classified areas gowning requirements.Qualifications included Matcon transfer containers, gel mass production and transfer tanks, Technophar soft gel encapsulator, Zed blister sealer packaging equipment, Vector Micro Fluid Bed and Key International High Shear Granulator.Aug. 2009  Jun. 2010, GSK (Bio-Pharm), Conshohocken, PA, Sr. Compliance ConsultantProvided plant expansion PLC/DeltaV CSV support. Specific areas were equipment & systems qualification, review of installed systems and equipment FATs and SATs. Preparation/execution of commissioning, IOQ protocols and RTMs for utility systems, WFI stills/CS generators, buffer, fermentation, purification, filtration and recovery systems for bioreactor cell culture production.Oct. 2005  Mar. 2009, Boston Scientific (Med Device), Maple Grove, MN, Program ManagerProvided CSV support for the equipment and systems for Software Quality Assurance (SQA), SDLC and software used in the manufacture of self-expanding and balloon expanding stents.Assisted in producing/approving project deliverables including Master Validation Plans (MVP), FMEA, URS, FS, RTM, IQ & OQ test procedures and reports, Final Validation Reports, CAPA processes and Change Control.Equipment included computer-controlled laser cutting, salt bath processing, wet line processing, electropolishing, Visicon stent inspection and stent delivery system, final packaging and inspection. Met classified areas gowning requirements.Received Boston Scientific Technology Award for Automated Stent Inspection System.Dec. 2004  Aug. 2005, Wyeth (Pediatric Vaccine), Sanford, NC, Sr. Validation EngineerLegacy audit/GAP analysis of PLC/SCADA systems for WFI systems, autoclaves, fermentors, lyophilizers, ultrafiltration and chromatography skids for 21 CFR Part 11 Compliance. Met classified areas gowning requirements.Oct. 2004  Dec. 2004, Baxter (Blood Fractionation), Glendale, CA, Controls EngineerExecuted DeltaV DCS Control and Data Acquisition protocols.Dec. 2003  Aug. 2004, AMGEN (Bio-Pharm), West Greenwich, RI, Sr. Validation EngineerPrepared/executed WFI still/CS generation/distribution, autoclaves, lyophilizers, DeltaV IO/OQs for buffer preparation, filtration, distribution for 20K liter bioreactors cell culture for Enbrel production. Met classified areas gowning requirements.Jul. 2003 - Nov. 2003, Mannkind Pharmaceutical (Pharm Manuf.), Danbury, CT, Sr. Val. Eng.Evaluated documents for and prepared qualification documents for packaging, compressed air and nitrogen systems at a pharmaceutical facility preparing for full scale manufacture.Jan. 2002 - Jul. 2003, Wyeth (Bio-Pharm) Expansion, Andover, MA, Sr. Val. Eng.Wrote/executed CSV protocols & CAS (DeltaV/PLC) for cell culture, product purification, harvest, buffer & media preparation processes and utilities for manufacturing & clinical suites expansion.Oct. 2000 - Dec. 2001, Astra-Zeneca, (Pharm. Manuf.), Westborough, MA, Sr. Val. Eng.Wrote/executed IQ/OQs for Pulmicort respules, sterile liquid filling, gels, ointments, creams, heat sealing & packaging operations. Protocols included PLC/computer-related systems CSV, facilities and process equipment qualification; prepared system specifications and protocols; developed SOPs and annotated process control diagrams; on-site testing; data analysis; and final reports. Performed & and utilities Gap Analysis. Met classified areas gowning requirements.Jun. 1998 - Sep. 2000, NORAMCO (API), Wilmington, DE & Athens, GA, Val. SpecialistPerformed new DEA facility equipment capability studies, developed IQ/OQ/PQ protocols for Pharm Class Water, compressed air, nitrogen, reactors, dryers, and HVAC/clean rooms.Feb. 1997 - Jun. 1998, Roche, Pharmaceutical Bulk API, Florence, SC, Val. SpecialistVerified commissioning compliance, performed walk downs, P&IDs & PLC programming, wrote and executed IQ, OQ & PQ protocols for water systems, steam, nitrogen utilities, HVAC/Clean Room, reactors, centrifuges & production equipment.Education: BS Chemical Engineering, Drexel University, Philadelphia, PACourses: Computer Programming, Pennco Tech, Bristol PAAllen-Bradley PLC Programming, Robeson County Community College, Lumberton, NCComputer Systems Validation: Pharmaceutical Manufacturing, CPAMicrosoft Project, New Horizons Computer Learning CenterComputer Proficiency:Systems: Windows, DCS, SCADA, Allen Bradley PLC, DeltaVSoftware: MS Word, Excel, Access, Project, Outlook, Adobe, MathCad, PSI-Plot, TrackWise,Blue Mountain Software CMMS, Master Control (QMS)Safety Training: OSHA 40 Hour Hazwoper OSHA 29 CFR 1910.120 & 1926.65Professional Affiliations: International Society for Pharmaceutical Engineering (ISPE)