Validation Specialist

Wesley M. Hyman

Senior Validation Specialist

Phone: 443-***-**** Cell or Home: 919-***-**** Email: ******.*****@*****.***

Professional Experience Summary

Validation Engineer with vast experience in computer and equipment validation protocol generation and execution, generating and approving Validation Plans, and coordinating and overseeing validation efforts and deliverables for all facets of computer validation of various systems including CIP/SIP,Trackwise, ISOtrain, AERS, SCADA, ERP, LIMS, HVAC, PLCs and DeltaV. Extensive knowledge of GAMP, cGMP, 21 CFR Part 11 and other FDA related standards. I have vast experience writing all documents used in the Software Development Life Cycle (SDLC) and have written and executed Test Protocols and Summary Reports related to SDLC in a regulated environment. I have authored Real Time Trace matrices and Risk Assessments as well. I have performed safety analyses using Fault Tree Analysis too.

Work Experience

02/2008 – 02/2010 Invensys Process Systems, Cary, NC

Senior Validation Engineer (08/09 – 11/09) Tatum, TX

- Worked on Computer Security for Power Company in east Texas. Wrote validation to achieve NERC Compliance. Also wrote SOPs and policy guidelines on computer security and network security for coal and steam generation power plant.

Senior Validation Engineer (10/08 – 03/09) Swiftwater, PA

- Worked on CIP cleaning validation systems. Writing protocols for cleaning studies. Also executing protocols and preparing summary reports. Working on Girton and Crest Sonicator systems used to clean 100L, 200L, 250L and 500L tanks.

Senior Validation Engineer (07/08 – 10/08) Greenville, SC

- Responsible for work on validation of Enterprise Resource Planning (ERP) systems application (MAPICS), this is a COTS software package. Responsible for writing, reviewing, and approving of Operational Qualification / Performance Qualification (OQ/PQ) protocols. Providing technical guidance for compliance of 21 CFR Part 11, and adherence to the Therapeutic Goods Administration (TGA) cGMP for Australia.

Senior Validation Engineer (02/08 – 07/08) Devens, MA

- Responsible for writing, reviewing and approving Validation Master Plans, User Requirements Specs, Functional Requirements Specs, DDS, and IQ/OQ/PQ protocols. Coordinate validation activities for multiple validation projects and perform CSV Risk assessments. Currently working on Inventory/Materials Management systems applications.

11/2006 – 11/2007 Sepracor, Inc., Marlborough, MA

Senior Computer Validation Engineer

- Responsible for reviewing and approving IQ/OQ protocols and developing PQ protocols. Write and approve Validation Plans and coordinate validation activities for multiple validation projects and perform CSV Risk assessments. Currently working on Adverse Events Reporting System (AERS) and Oracle Clinical systems applications.

07/2006 – 11/2006 Alkermes, Inc., Cambridge, MA

Senior Computer Validation Engineer

- Validation duties included preparing, reviewing and approving IQ/OQ protocols, Computer Validation Plans, CSV assessments; Gap Analyses; revising SOPs; and overseeing validation efforts and deliverables for all facets of computer validation of various systems including Trackwise, ISOtrain, SCADA, and other areas.

06/2004 – 05/2006 MedImmune, Inc. Frederick, MD

Validation Engineer III

- Responsible for validation activities for multiple validation projects. Duties included preparing Master Validation Plans (MVP), CSV assessments, Gap Analyses, creating and revising SOPs, overseeing validation efforts and writing (IQ/OQ/PQ) for various systems including BAS, SCADA, PLCs and others.

04/2004 – 06/2004 American Red Cross, Falls Church, VA

Test Engineer

- Responsible for validation activities for multiple projects including setting up a computer test lab environment. Duties included reviewing, approving and executing IQ/OQ/PQ, preparing Validation Plans, performing high-level 21 CFR Part 11 CSV assessments, overseeing validation efforts and deliverables for all facets of computer validation of various systems used for blood collection and related applications.

03/2003 – 04/2004 Alpharma USPD, Baltimore, MD

Validation Engineer

- Responsible for writing and executing IQ/OQ/PQ, preparing Validation Plans, overseeing validation efforts for various manufacturing systems including CIP/SIP, HMI, 5000L tanks, Packaging, Compounding, Kaye Validator 2000, Millennium Waters, LIMS, PLCs and other areas.

03/2002 – 12/2002 Oxford Global Resources, Inc Beverly, MA, sub to Rockwell Automation, Inc. Eli Lilly IN.

Validation Coordinator

- Responsible for preparing Master Validation Plans, assessing Factory Acceptance Tests (FAT), performing high-level 21 CFR Part 11 assessments, creating and revising SOPs, overseeing validation efforts for HVAC, SCADA, PLCs and other areas controlled by DeltaV.

08/2001 - 03/2002 Mintanciyan Consulting Inc., New City, NY (Schering-Plough)

Computer Validation Specialist, biopharmaceutical manufacturer in Las Piedras, PR

- Performed cGMP and 21 CFR Part 11 assessments for computer related systems for Information Systems, Manufacturing, Packaging, Laboratory (Chemstations, Mass Spectrophotomers, etc.), Engineering and Maintenance, and Utilities applications to identify gaps and compliance levels for adherence to FDA guidelines. Introduced to DeltaV. Assisted in preparation of commissioning studies for manufacturing related applications.

08/2000 - 07/2001 Valicor & Associates, Inc. Cary, NC

Computer Validation Consultant, Wyeth

- Duties included validation of computer-related systems, manufacturing facilities, and process equipment. Preparation and/or review of requirement specifications and qualification protocols and analysis of 21 CFR Part11 compliance. On-site protocol execution; data analysis; and preparation, review and approval of final reports. Also performed audit of warehousing processes. Qualification of a Computer System Application including IQ/OQ protocol generation, execution and final report generation.

09/1999 - 07/2000 KMI/PAREXEL Durham, NC

Validation Specialist

- Duties included validation of computer-related systems, manufacturing facilities, and process equipment; preparation and/or review and approval of requirement specifications and qualification protocols; analysis of 21 CFR Part11 compliance; preparation and/or review of standard operating procedures (SOPs); on-site protocol execution; data analysis; and preparation and review/approval of final reports. Qualification of a Stability System Application (IQ/OQ/PQ). Qualification of a Customized Laboratory Data Acquisition and Calculation Application (IQ/OQ/PQ) protocol execution.

04/1999 - 09/1999 Graydon Corp. Contract to Bayer Corp. Clayton, NC

Sr. Validation Analyst

- Responsible for performing Y2K validation on various manufacturing systems. Duties included writing and executing test plans for applications, contacting vendors regarding Y2K compliance and developing test strategies.

10/1998 - 04/1999 Unisys Corp. Raleigh, NC, QA Test Engineer, USPS

09/1998 - 10/1998 Judge Technical Services, Sr. QA Analyst, IBM

04/1998 - 08/1998 Cornell Technical Services, Testing Lead Analyst

08/1997 – 04/1998 COMSYS Inc., Test and Certification Coordinator, NORTEL

08/1996 - 07/1997 SEER Technologies, Inc. Cary, NC, QA Analyst

04/1996 - 07/1996 Sai Software Consultants Inc., QA Test Engineer, HealthPoint

09/1995 - 04/1996 Metro Information Services, Raleigh, NC, Systems Test Analyst, AT&T

08/1995 - 09/1995 Tech Specialists, Inc. RTP, NC, Software Test Engineer

07/1993 - 07/1995 TDS, Inc. Charleston, SC, QA Test Engineer

11/1991 - 07/1993 Atlantic Research Corp. Havelock, NC, Sr. Programmer Analyst

09/1991 - 11/1991 Volt Technical Services San Diego, CA, QA Engineer

05/1990 - 07/1991 Vitro Corp. San Diego, CA, Sr. Software Engineer

05/1988 – 03/1989 WES COAST ENTERPRISES, LTD.

04/1989 – 09/1989 Tracor Applied Sciences, Inc. San Diego, CA, Systems Analyst

10/1983 - 04/1988 Computer Science Corp. San Diego, CA, Sr. Test Technician

10/1982 - 10/1983 Science Applications Inc. (SAIC) San Diego, CA, Computer Analyst

10/1978 - 10/1982 Systems Development Corp (UNISYS) San Diego, CA, Computer PA

Education

1982 Bachelor's Degree National University, San Diego, CA

BS Computer Information Systems.

Languages Used

 C,C++,CMS-2Y,FORTRAN- 66(-77,-IV,-V,-VII),SP-1 Assembler, SQL, ASSEMBLER,BASIC, COBOL, FORTRAN, PL/1, RPG III, Solaris, SunOS, Berkeley Unix, CMS-2, HP-UNIX, DG-UX, MS-DOS,OS/32, RSX-11, SDEX, VAX/VMS, VAX CM/VMS, Windows 3.1, Windows NT (95, and 98) SUN IPC(IPX), SPARC, Compaq, Concurrent 3212, DEC, Harris 800, HP 9000, IBM-SP1,IBM-PC, Macintosh, PDP 11/70, ROLM 1666, UNIVAC AN/UYK-7(-2-,-43,-44),UNIVAC

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