Glenn Sward

Validation Engineer

Primary Phone: 269-***-****

E-mail Address: acz8sz@r.postjobfree.com

Glenn Sward

Objective: To continue my career development in the Pharmaceutical/Medical Device industry utilizing my technical skills as well as my knowledge of quality systems, and compliance in cGMP regulated environments while extending my knowledge and experience providing high quality healthcare and service to companies and organizations resulting in profitable growth.

Summary: Over sixteen years validation experience working with quality systems for Laboratory Instrumentation, Equipment, Utilities and Facilities in GMP regulated environments. Ten years direct experience with laboratory and manufacturing equipment protocol execution. Validation experience consists of the following detail:

• Global Serialization Process

• Commissioning: IQ for PLC and Batch Control Systems (automation)

• Medical Device IQ\OQ\PQ and commissioning for manufacturing equipment

• Process Validation for liquid fill and tablet producing lines

• Qualification of biomedical and chemistry instrumentation

• Temperature mapping using trend smart reader data loggers

• Protocol, report, and non conformance / deviation writing

• IQ/OQ/PQ data generation and execution

• P&ID drawing verification and redlines

• Trained and performed work under Consent Decree for Medical Device manufacturing

• Gap Assessments, Risk based Assessments, Periodic Validation Review

• Cross Functional Team decision process for resolutions with QA, R&D, Manufacturing, and Engineering

• Write and revise procedures and specifications for validation

• Cleaning validation for equipment and facilities

• Quality Systems Documentation Review and Engineering Change Request initiation

• Lead validation teams. Developed and trained employees

• QA Review

Employment History:

03/2015-Current System Analyst – Tata (TCS) Consulting

Commissioning and Qualification Subject Matter Expert (SME) for Global Serialization project providing Level 2 support to 5 countries.

06/2012-03/2015 Validation Specialist – Corium International

Create and perform assessments for equipment. Design Specification development and IQ/OQ/PPQ for equipment and control systems. Teamwork with engineering and process development departments for validation and specifications. Create Validation Master Plan. Improve quality system. IOQ for manufacturing lines (transdermal patches) and manage quality systems. Train new employees. Review and approve Engineering Change Requests.

03/2012-06/2012 Validation Engineer - Validant Consulting

Performed GAP and Risk Assessments for pharmaceutical manufacturing equipment. Commission equipment. Protocol development with control systems. Peer review prior to submittal to client. Communication with client for requirements and end results for testing criteria.

Employment History:

08/2011-02/2012 Lead Facilities Engineer - Iconma / Life Technologies

Conduct and coordinate operations with Validation, Calibration, external vendors and Corporate policies. Respond to audit observations and address CAPA’s. Implement quality systems for facilities, utilities and equipment. Coordinate vendor services. Direct vendor services and oversee their functions. Direct oversight of other functional departments (production, operations and validation). Maintain building and

equipment while providing engineering documentation and recommendations. Write and perform work orders. Delegate work to subordinate personnel. Responded to (BMS) system monitoring alarms.

01/2011-08/2011 Array Technician/Operator - Nanosphere Inc.

Manufacturing and Development of Array for medical diagnostic instruments (Nanotechnology). Review and Revise SOP’s, review laboratory records, maintain laboratory equipment and records including lab books, stock and maintain supplies, clean labs, pipette reagents and solution for production and analysis. Perform any necessary activities as directed by lab manager. Perform Calibrations and Preventative Maintenance. Run Nanoplotters for production, review Batch Records. Monitor chart recorders.

10/2010 - 1/2011 Validation Engineer Manpower Professional / Abbott Laboratories

Performed protocol execution for pharmaceutical operations, Process Qualification, Engineering Studies. Electronic routing for protocols (Author / Approver in VMS)

08/2010 - 09/17/2010 Validation Engineer – Chicago Controls / Abbott Molecular

Gap Assessments, Periodic Reviews, Seasonal assessments for Purified Water and Automated Process Control Systems. Identified gaps from previous qualifications and resolve them.

10/2009 - 06/2010 – Validation Engineer - RxGlobal

Process validation for manufacturing lines, Qualified Ethanol Dispensing system, Formulation and Holding tanks. Review execute and approve protocols and write reports.

Quality Assurance review for manufacturing lines and equipment.

Protocol execution review and documentation for SAT, FAT, URS, DS, IQ/OQ/PQ. PLC and Automated software systems protocol execution.

Executed and resolved 3,000 pages of SAT’s in 3 months and resolved 52 deviations.

9/2007-11/2008 Senior Validation Engineer – ProPharma Group

Clients: Medrad, Van Andel Institute, PharmOptima, Aptuit, Boehringer-Ingelheim

GMP regulated SOP and IOQ/PQ protocol development, review, and execution for medical device manufacturing facilities and equipment based on FAT, FRS, URS, and SOP’s. HVAC, Clean Steam, Nitrogen, Autoclaves, Washers, Temperature/RH, Particulate and Pressure Monitoring Systems. Batch Record review, Autoclave protocol development and execution. Protocol development for manufacturing line and packaging equipment including Vision Inspection Systems. Advise manufacturing management for guidelines, regulations, and risk.

Employment History (continued)

9/2006-9/2007 Validation Specialist – cGMP Validation L.L.C

Clients: Pfizer, Nostrum Laboratories, Alkermes, and Amylin Pharmaceuticals,

GMP regulated Commissioning, PLC IQ, SCADA, and Software protocol testing and development, P&ID verification, Electrical system verification, IQ/OQ. Protocol writing and execution for Equipment, Facilities, Utilities, and report writing for Batch Control Systems and utilities based on FAT, URS, and SOP’s. Resolved issues with QA, manufacturing and engineering for Deviations and Root Cause Analysis. Medical Device manufacturing

5/2006-9/2006: Validation Specialist - K-Force/Perrigo Company

GMP regulated Protocol, Deviation, and Report writing for execution of packaging validation systems (PQ). Objective to challenge label claim and tablet weight. Worked with manufacturing, QA, management and engineering for Corrective and Preventative Actions and Root Cause Analysis for Deviations.

1/2005 - 5/2006: Validation Engineer Level I

Manpower Professional (contract for Abbott Laboratories)

Objective A: GMP Protocol execution, final report writing IQ/OQ, Non Conformance resolutions, Immunoassay instrument qualifications. Resolved issues with QA, manufacturing and engineering for Non Conformances and Root Cause Analysis.

Objective B: GMP & R&D Temperature profiling of freezers, coolers, and incubators. Prepare, review, and execute protocols and documentation and direct subordinate personnel.

08/2003 - 6/2004: Validation Technician

Manpower Professional (contract for Abbott Laboratories)

GMP and R&D Electrical Verification, Documentation, Validation, Protocol and report writing, Calibration and Preventative Maintenance verification and resolution

12/2001 - 3/2003 Qualification Engineer - Abbott Laboratories Employee

Abbott Diagnostics Division

Protocol execution and qualification for Instruments. Temperature mapping for freezers, coolers and incubators. Quality systems review. Assigned to special projects.

4/2000 - 12/2001 Engineering Technician / Lab Assistant – Abbott Laboratories

Badger Technical Service (contract for Abbott Laboratories) deployed to Abbott Diagnostics Division

GMP and R&D. Established methods used for communicating various business teams and

Inventoried equipment * Repaired biomedical instruments * Established Pre-qualification program to reduce time and cost savings of approximately $60,000* Generated work orders and scheduled preventative maintenance for laboratory equipment

Education, Licenses and Certificates:

McHenry County College

IL; General coursework

University Of Phoenix

General coursework

Goals:

Project Management / Quality Management

Develop skills and fulfill company needs resulting in profitable growth

Continue learning and development of new systems and processes and cross training

Develop other employees

Certificates and Licenses:

ARCHITECT Field Service Technician Instrument repair and operation, Abbott Laboratories, TX

ATLAS (Maximo) Maintenance Management, North Chicago, IL

Subject Matter expert for Abbott immunoassay biomedical and clinical chemistry instruments.

Skills and Abilities:

Facilities Engineering* Management* Computerized Systems* Technical Writing *Instrumentation and hardware analysis * Mechanical repair * Testing * Supervision of personnel * Market and promote services * Customer Support and Relations* Documentation * Implementation of programs * Trouble shooting * Trained on cGMP(GxP), 21 CFR 210, 211, 58, 820, 14644. GDP, GLP, GCP, Safety and QA review * GAP Assessments * Develop and worked with various business teams *Expert in protocol execution with CAPA Resolution, Change Control. Medical Device manufacturing, Batch Record Review

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