Software Medical Device

Denis Machoka

Email: abp1a7@r.postjobfree.com

Address: **** ******* ****

City: Raleigh

State: NC

Zip: 27617

Country: USA

Phone: 515-***-****

Skill Level: Management

Salary Range: $110,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

D E N I S M A C H O K A

OVERVIEW

Results-oriented Technical Expert with more than 15 years of experience within the pharmaceutical and medical device industries. Focused on delivering project deliverables on time and on budget, while ensuring employer satisfaction. Experienced in managing various size project teams through the project life cycle. Skilled in managing multi-cultural teams. Develops and maintains key cross-functional relations with internal and external business partners. Effectively communicates with senior leadership to production operators. Most recently serving as a Sr. Software and MES Quality Engineer for Software projects in a Fortune 500 medical device manufacturing company.

PROFESSIONAL SUMMARY

Project Management

Most recently developed a global software quality system, led international Deployment of VISIONAIRE Patient Match Technology to India while leading legacy software, manufacturing equipment remediation of a site-wide production. Experienced in effective global project planning. Participated in and guided team design and recruiting. Provided consistent direction to project teams. Experienced in product-based planning techniques to identify key deliverables and dependencies. Demonstrated creative problem-solving skills. Developed and maintained key cross-functional relations with internal business areas (engineering and scientific) and supported Corporate IT departments. Experienced in developing, tracking and reporting project metrics. Advocated and adhered to consistent change management protocols. Focuses on the "Big Picture" without losing site of the details.

Medical Device Sterilization/Cleaning Experience

Familiar with the application of FDA/ISO regulations related to medical device cleaning and sterilization. Developed documents related to cleaning policy, SOP development, cleaning process validation, developed sterilization validation deliverables such as risk assessment and IQ/OQ/PQ. Completed projects involving clean room and sterilization the projects were at Abraxis (Isolators, laboratory, clean room validation, at Boston Scientific and Shire Pharmaceuticals developed and reviewed documents related to validation of autoclaves, ovens and dishwashers.

Computer Systems Compliance Assessment & Analysis

Conducted Part 11 Risk Assessments on over 280 software systems worldwide assigning a risk category of high, medium, or low based on system's intended use. Determined GxP applicability and identified applicable predicate rule. Authored Compliance Assessments and Corrective Action Plans for all high-risk systems and key medium and low-risk pharmaceutical systems ranging from lab equipment, such as HPLCs and Spectrophotometers to Digital Control Systems for manufacturing plants, Building Management Systems, Stability Chambers and Purified Water Systems. Conducted detailed interview sessions with Business Managers, System Owners, and Expert Users for computerized systems. Advised client system owners on 21 CFR Part 11 applicability and remediation options. Facilitated acceptance of assessment findings.

Software Auditor

Created a system for auditing computerized vendors. Implemented this by drafting SOP's, Audit and questionnaire templates and report templates. Identified business requirements unique to software classification based on Risk. Standardized audit procedures though 3 sites. Based on User Requirements conducted several successful Software/computer Audits. Specifically, created detailed Audit checklists, Audit plan and upon completion of Audits, Compiled Audit Reports. Reviewed findings, addressed concerns to Senior Management and Conducted follow up meetings that addressed implications of audits and vendor commitments.

Validation Expert

Experienced in Laboratory Method Validations, Process Validations, Cleaning validations, Building Automations Systems, Microbiology Laboratory Validations, Facility Commissioning, Legacy Equipment Validations etc. Successfully performed over 200 different Software and Equipment Validations, reviewed validation protocols from consultants, vendors and internal resources. Managed a validation effort across multiple sites in the US and Canada. Experienced in the application GAMP methodologies.

Product Testing and Laboratory Expert

Coordinated revalidation of Analytical Methods and improved methods to meet USP standards, implemented new cleaning programs, developed a cleaning matrix, reviewed cleaning and validation documents, Expanded laboratory activities to include the purchase and validation of new microbiology laboratory and validated the Biolog, furnace/Autoclaves and Isolators. Developed analytical methods for EPA, NPDES (Testing Methodologies for National Pollutants). As part of an elite team from Oklahoma State University, developed a sensing algorithm method used by TSA in Airports.

Regulatory Affairs Representative

Experienced filing 510(k)'s/PMAs/IDEs/ NDA and ANDA submissions. Interacted with the FDA representatives in audit. Responded to FDA's 483 issuance. Lead implementation of new Quality System that included overhaul of the Change Control System, CAPA, Complaints, Product Testing and Product Release Cycle, Regulatory Compliance, Internal Auditing etc. Re-created new Quality plans, MBR (Master Batch Record) Template and quality documents used in manufacturing. Expert at applying GLP, cGMP, GXP, ICH, ASHRAE,ISO,WHO and HIPAA laws. Developed procedures for DEA's regulations involving FDA's CFR 1300 for schedule 1 and 2 drugs. Experienced in the practical application of the FDA regulations-both the "letter of the law" and their implied requirements. Experienced at performing Software Quality Audits for both ISO 9001:2000, BS EN 62304-2006 and 13485.

Quality Assurance Document Reviewer

Review documents for regulated systems for compliance. Previously has served as a remote Quality Assurance Reviewer for Pharmaceutical and Medical Device companies. Projects documents reviewed have included those related to Legacy Remediation of pharmaceutical equipment and automated systems; the implementation of new liquid filling lines. Reviewed multiple project validation documentation packages for technical accuracy, adherence to Good Documentation Practices (GDP), corporate SOPs, and regulatory compliance (21 CFR Parts 11, 210, 211, 62304 and 820). Served as document approver to Validation Consultants and Sr. Staff.

EXPERIENCE

February 2011 - November 2012 Smith & Nephew Inc. - Software Quality Memphis, TN

Manager Software Validation (Advanced Surgical Devices Division)

Provide global multiple project leadership and creating an integrated Global Quality Software System with a team of software engineers that include leading the remediation of legacy and validation existing software. Provide expertise and technical guidance regarding all aspects of software applications for medical products, manufacturing systems, and software validation. Guide all global locations in the validation of manufacturing systems, web based applications, and medical device software. Interact with all levels of management to communicate software validation requirements and project schedules. Perform Audits of software applications and systems, develop software validation specifications, software validation master plans and Establish controls for the software lifecycle. Represent global software validation team in internal and external audits.

September 2009 - February 2011 Boston Scientific Corporation - Software Quality Spencer, IN

Sr. Software Quality Engineer

Provided QA support for software changes, validation and remediation efforts for over 200 separate computer systems and manufacturing equipment for the Spencer site and lead the Legacy Software Remediation team. Review documentation related to all changes, Validations, Revalidations and analyze existing corporate computer systems for applicability to site, determine software quality risk based on intended use and recommend actions based on internal and corporate procedures. Team Members include 10 Software Validation Engineers, 1 Equipment Tech and 1 Co-Op.

Other responsibilities include:.

* Develop software system integrations, validations and remediation strategies for BSC Global

* Review and approve all Spencer Site Quality System Software updates, upgrades, patches and software changes

* Represent QA in new software implementation, upgrades and validation projects

* Serve as site Sr. Software Quality Systems Advisor to Sr. Management in Software Review Boards

* Co-ordinate and review software remediation and retirement documents on site. Train junior engineers on Software Validation requirements

* Perform system administration role for DaCs software system

* Review validation deliverables for tools such as Excel, data queries used in Management Reviews

* Standardize the intent and application of change management systems such as PCAF, QMAC and DCAF validation standards within BSCI.

* Review protocols and documents related to Legacy software retirements. Review and approve documents such as : Intended Use, Software System Assessment, Part 11 ERES assessments, Validation Plan, Remediation plans, Software Design Requirements, test plans, Traceability Matix, Test Protocols with results and Validation Reports

Sr. Quality Engineer MES (Manufacturing Execution System)

Provide eMfg QA Support for implementation of MES to 23 manufacturing lines at Spencer facility starting with the Interject line. Improve processes by integrating MES into Spencer and global Quality System. Develop and update documentation for the control of activities involving MES within the site. Confer with senior management on issues and impact of the MES system on existing quality system.

Other responsibilities include:.

* Represented Spencer site interests to the Global MES Team

* Serve as site MES Quality Assurance Advisor to Sr. Management

* Identify and update Site SOP's affected with Change.

* Create, review, comment, and approve MES-related change requests related to workflows and product instances

* Co-ordinate MES upgrades, Business Simulation and Cut over Activities related to line upgrades to MES

* Perform process improvements within site and MES application functionality

Systems: Camstar Insight application, Windchill 9.1 Product Development Data Repository, DaCs.

September 2008 - January 2009 Shire Pharmaceuticals- Quality Owings Mills, MD

QA Validation Manager

Led a team of 4 in the remediation of over 114 legacy manufacturing equipment and revalidation initiative for entire facility. Participated in the development and execution of cleaning validation. Approved and reviewed all high risk equipment validation protocols and cleaning validation documents

Responsibilities included:

* Led projects that involved all equipment risk assessment and then recommended approaches to revalidation of a solid dosage facility manufacturing equipments.

* Reviewed completeness of the validation efforts of existing systems

* Expert in clean rooms, environmental monitoring, facility design, building commissioning, HVAC etc

* Developed and executed master cleaning plans for multi-product parenteral facilities and solid dosage manufacturing facilities.

* Aided client in the development of cleaning processes and validation of sampling procedures (Swab identification, Matrix creation) and evaluated suitability of analytical methods.

January 2007- September 2008 PharmaSys Inc - Computer Validation Cary, NC

Project Manager and Sr. Consultant

Performed various Computer Systems Validation for several companies

Stiefel Laboratories, Oak Hill NY

Validated entire building structure of Stiefel's manufacturing facility including the BMS system

Reviewed and audited documents by previous consultants

Leiner Health Products Wilson NC

Data mined and verified questionable analytical data of results

Performed computer system compliance gap assessments and reporting

Performed 21 CFR Part 11 system assessments and reporting

Leiner Health Products Fort Mill SC

Performed Electronic Batch Record reviews and laboratory data integrity mitigations. Updated SOP's

Leiner Health Products Garden Grove CA

Audited Validation methods for an entire company and authored Validation Method Gaps Reports

Nature's Bounty Carson CA

Conducted Software & Quality Audits for both ISO 9001:2000 and 13485, Performed computer system and component risk assessments Performed training and acted as a remote administrator for their client server system

The Henry Jackson Foundation of Military Medicine (HJFMM) Gaithersburg MD

Validated their proprietary clinical data software and Trackwise software for handling their clinical trial information

Responsibilities included:

* Developed and expanded business to the Midwest and west coast regions

* Ensured correct number of consultant resources were hired for various projects

* Communicated and negotiated contracts for consultants and contractual extensions

* Managed project deliverables

* Coordinated the contractual agreements

* Reviewed validation protocols, master plans, projections and approaches

* Acted as a remote administrator to their client server system

September 2006 - January 2007 Omni Care Toledo, OH

Sr. Consultant

Assisted the company design quality management system for the development or manufacture of medical products that met the design control regulations of 21 CFR 820.30 or EN 46001 and the GMP requirements of 21 CFR 211, 606, 820. These systems would facilitate design control, validation, change management (unexpected and planned change), and documentation. Developed SOP's for the control and testing for the lidding material

January 2006 - September 2006 Sun Pharmaceuticals Industries Ltd Bryan, OH

Quality Control Manager

Wrote a response letter to FDA's 483 observations, completed a mega interdepartmental project to implement corrective actions to the FDA observations. Implemented laboratory automation, software qualification and paperless initiatives

Experienced with the United States, Arab, Canadian and European Community guidelines which reference to ISO requirements for medical devices and medicinal products, Served as a training manager for the company for the following business units: compliance services, automation integration, IT solutions, and software development, Developed and maintained corporate QMS for products and services across all business units of the organization, Implemented industry standards in SDLC for product development, Provided Oversight and management of web-based change control / product issue resolution system. Developed procedures for DEA's regulations involving FDA's CFR 1300 for schedule 1 and 2 drugs

January 2005 - January 2006 Qualis Inc Des Moines, IA

QA/QC Laboratory Manager

Proficient in USP-NF Product Testing Methodologies for Solid and Liquid Dosages. Led a project to upgrade analytical methods for a company to claim "tested per USP". Developed analytical methods for EPA, NPDES (Testing Methodologies for National Pollutants). Expert in HPLC equipment validation, troubleshoot, and repair

Hired over 20 new chemists in response to added laboratory load Completed the purchase and qualification of Stability Chambers, GC's, LC's and misc Lab equipments. Designed validation protocols for the validation and continued monitoring of systems used to generate "purified water" including carbon filters, water softeners, reverse osmosis (RO) systems, deionized water (DI) systems, and ultra-filtration systems. Designed validation protocols for the validation and continued monitoring of systems used to generate water for injection (WFI) and pure steam. The scale and complexity of these systems ranged from laboratory scale to large manufacturing plant systems with a multiple effect still, several storage tanks, and multiple recirculating loops. Performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes.

January 2004 - November 2004 Cardinal Health PTS Fort Worth, TX

QA/QC Laboratory Supervisor

As QA/QC supervisor lead a team of 40 analysts in the analysis and release of solid dosage products at Cardinal Health Products. Responsibilities included:

Managing the release and testing of Raw Materials and finished products. Initiated and completed Non conformances, reviewed analysts data, Trained new users in the use of the client server system, Fixed and maintained laboratory systems

Validated HPLC's

January 2004 - July 2004 Nomadics, Inc. Stillwater, OK

Associate Engineer

As a Research Engineer developed sensors and improved analytical methods for the testing of materials for the Dept of transportation and TSA as part of Airport Screening Sensory technologies

January 2002 - February 2004 ConocoPhillips Petroleum Company Ponca City, OK

Sr. Research Scientist

As part of a ConocoPhillips analytical team participated in a breakthrough research in identification of naphthenic acids and solution to corrosion, Managed 3 Laboratories and 5 technicians that included the wet chemistry Lab, GPC lab and the HPLC Laboratory, acted as lead for coordinating the testing and performing select tests for research and patent infringement investigations, Developed several technical reports based on continuous analysis of products that was used in winning a number of cases relating to patent infringements

1st Quarter'01 and March 2009-April 2009

Analytical Chemist Abraxis Biosciences Melrose Park, IL

Tested all incoming and finished products in their chemistry lab and recently created the validation documents for the commissioning of the new Micro Laboratory. These included documents for the clean room, fume hoods and validation of Isolators

2nd Quarter 2001 Pfizer. Skokie, IL

Data Entry Assistant- Compounding

3rd Quarter 2001 Incon Processing, Inc. Batavia, IL

Laboratory Manager

1st Quarter 2001 Citgo Petroleum. Lemont, IL

Laboratory Analyst

1999 Dow Chemicals. Joliet, IL

Laboratory Technicians

1998 Unilever. Channahon, IL

Chemist

EDUCATION

Undergraduate Degrees

B.A., Chemistry, . Lewis University, Romeoville, IL 2001

B.S., Biology, Lewis University, Romeoville, IL 2001

National Deans List 2000 & 2001

Graduate Courses M.S., Engineering Technology Management (MSET) Oklahoma State University Stwtr OK ok

M.S., Information Systems(IS) Strayer University (Current) ..VA

4.0 GPA Online

Certificates Earned

Waters NuGenesis SDMS Version 6.0.1 Administrator - Waters Corp.

Advanced HPLC Method Development - Rheodyne/LC Resources

Gel Permeation Chromatography (GPC) - Theory & Practice - Waters Corp.

Advanced Millennium V4.0 - Waters Corp.

Empower Software - Waters Corp.

PROFESSIONAL PUBLICATIONS, MEMBERSHIPS & TRAINING

Member ISPE -GL Chapter.

Member ASQ (American Society for Quality)

Effects of Napthenic Acids in Petroleum ConocoPhillips, Ponca City OK

Careers in Validation Workshop Romeoville IL

Computerized Systems Validation & Compliance - ISPE, Raleigh, NC

GMP Training Certificate - Sun Pharmaceuticals Industries, Bryan, OH.

ATHLETIC ACHIEVEMENTS

1999 NCAA Track and Field Champion 1998 Great Lakes Region Conference Champion

1998 Lewis & NEIU School Track Records 1998 Drake Relays Champion

1999 Chicagoland Champion 1996 World Intervarsity Games Championships

TECHNICAL SUMMARY

EXPERIENCE IN MANUFACTURING EQUIPMENT VALIDATIONS:

* Authored, Executed, Lead, Managed, and Reported on complete life cycle of system Validation deliverables

* DEPYROGENATION OVENS

o Despatch depyrogenation ovens, Gehnrich

* UTILITY SYSTEMS

o Clean Steam,

o Emergency Power Generators,

o Compressed Gases,

o DI Water,

o Plant Steam,

o Water-For-Injection (WFI),

o USP Water,

o AHUs (Air Handling Units)

* FILLING LINES

o Calumatic, Kaps Filling Machines

* LYOPHILIZERS

o Edwards and Hull

* STERILIZERS

o Getinge autoclaves

* LABORATORY EQUIPMENT

o Waters Empower, Atlas, Agilent ChemStation, Perkin Elmer, TotalChrom

* TABLET PRESS

o Elizabeth Hata, Fette

* BLENDER

o Patterson Kelly, Gallay, LB Bohle

* MILLS

o Fitzpatrick, Quadro Engineering,

* CHECK WEIGHER

o KKE 2500, IMA, Bosch

* CAPSULE FILLERS

o MG America, IMA

* METAL DETECTORS/POLISHERS/DE-DUSTERS

o Healthstar and Lock Inspection Systems

* PMA 1200/600/65/600 WET MILL

o Fielder, Quadro Engineering,

* MP-8/MP-6

o Aeromatic, Glatt

SOFTWARE:

* Experienced in SDLC methodologies such as: ANSI, AAMI, GAMP, IEEE, ISA, BS EN IEC and ISO.

* Balanced experience across embedded, standalone, and distributed systems.

* Experience in development (modest ladder logic / SFC programming / VB and SQL experience), Design Review, FAT, SAT (Commissioning and Qualification), Validation, On-Going Maintenance / Change and Configuration Management.

ENTERPRISE SOFTWARE VALIDATION EXPERIENCE

o ProcessPro,

o Excel

o ERP-Pro,

o JD Edwards (Citrix),

o BPCS.

o Qumas/Documentum -Electronic Document Management System (EDMS) with corporate scope

o Pilgrim,

o DataStream 7i

* Oracle Database in a client/Server environment

* DCS/MES

o Honeywell/POMS INCODE

o Moore/Siemens APACS

o RS Batch

o Werum PAX

o Camstar

o ProcessPro

* Most prevalent hands-on automation/controls experience with the following applications and development tools:

o RSLogix

o ControlLogix

o RSView

o PanelView

COMPUTER SYSTEMS VALIDATION EXPERIENCE:

* Authored, Executed, Lead, Managed, and Reported on complete life cycle of system Validation deliverables for all 5 GAMP categories of systems.

* COTS Software

o Unigraphics NX 7.5

o Bugzilla

o Subversion

o Geomagic

* Client-Server (DB) based Systems

o VISIONAIRE - Proprietary 3D Design Software

o Millennium32 V 4.0, Empower I and II

o Plims 2000,

o Sparta Trackwise

o LabWare LIMS,

o SQL*LIMS

o JDEdwards,

o BPCS

o VB/HTML/SQL-based Manufacturing Data Management System (MDMS)

o Bespoke/Custom Oracle database application to track product complaints, adverse event reporting

o E-Flexion Automated Data Management System

o PAT toolkit (VB, .NET, SQL)

o OSI PI

* Standalone PC-based Systems

o MS Access database programs including a system to track controlled substances

o Specialty Measurements International (SMI) data acquisition systems

o MS Excel Spreadsheets

* DCS/MES

o Honeywell/POMS INCODE

o Moore/Siemens APACS

o RS Batch

o Camstar

* PLC-based Utility Systems (HMI and SCADA)

o Honeywell BAS, Andover Controls BAS/BMS, Johnson Controls HVAC, Johnson Controls RO SCADA,

* PLC-BASED PROCESS SYSTEMS (HMI AND SCADA)

o Bulk Sterilizer tracking system, BioPass Chromatography, BioCAD HPLC, Glatt Fluid Bed Dryers, and Niro Spray Dryers, Bespoke

* PLC-BASED EQUIPMENT (HMI AND SCADA)

o Despatch depyrogenation ovens, Gruenberg depyrogenation ovens, Getinge autoclaves, Edwards and Hull lyophilizers

* DATABASE/ NETWORK VALIDATION

o Lotus notes,

o Oracle,

o Discovery Networks

Platforms: Windows 7,Windows XP, 2000, 98, 95, Macintosh, Oracle, SQL Server, Unix, MSCRM and Citrix.

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