Engineer Control

Senior Validation Consultant

Mark C. Weinglass 1306 Oberlin Rd

302-***-**** (home) Wilmington, DE 19803

302-***-**** (cell) E-mail: *************@*****.***

Key Experience

FDA compliance (cGMP, GLP, 21 CFR Part 11, EU Annex 11, QSR), process control, authored

regulatory documents, control system and SCADA programmer, audits of manufacturing facilities,

regulatory remediation, control system design. Experience with field and lab instrumentation,

manufacturing and diagnostic equipment, software and hardware validation.

PROFESSIONAL SUMMARY

EDUCATION: University of North Carolina at Charlotte

Bachelor of Science in Electrical Engineering

PUBLICATIONS: “How to ‘Right-Size’ Computer System Validation Based on Criticality and

Complexity” – co-author. Article published in the Journal of Validation

Technology, Autumn 2010 edition.

PROFESSIONAL EXPERIENCE:

2/04 - Present EduQuest

Senior Validation Consultant

• Coordinated regulatory remediation projects for medical devices such as Peritoneal Dialysis,

Genetic Analyzers, Infusion Pumps, Parenteral Compounders, Blood Analyzers, Oxygen Level

Analyzers, and Magnetic Cell Separators.

• Provided guidance to pharmaceutical and medical device facilities on how to achieve and

maintain compliance with FDA regulations and ISO 13485.

• Remediation projects to meet cGMP, 21 CFR Part11, and QSR.

• Qualification activities: IQ, OQ, PQ, EQ and SLC/SDLC to include all facets of document

preparation, including writing, reviewing, and approving.

5/01 – 2/04 QA Edge (Assigned to AstraZeneca)

Senior Validation Consultant

• Coordinated validation remediation effort bringing into FDA compliance ten major systems which

were not in compliance with cGMP and Electronic Records; Electronic Signature Regulation

(21CFR Part 11). Systems included: adverse reporting; recall notifications; electronic imaging and

regulated document management; product stability and expiration dating analysis; shipping,

warehousing, and distribution of sample products.

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• Major activities included: development of project scope and approach; planning, estimating, and

scheduling; writing master validation plans (MVP), user requirements (URS), System Design

Requirements (SDS), Installation Qualifications (IQ), Operational Qualifications (OQ), Process

Qualifications (PQ), Test Plans (TP), Test Scripts (TS), and final Validation Reports (VR).

• Developed System Life Cycle (SLC) documents and Standard Operating Procedures (SOPs)

based on regulatory risk, system complexity, and criticality.

6/98 – 5/01 EduQuest

Senor Validation Consultant

• Served as team lead and supervisor: SOPs, validation documents, manuals for equipment,

software, hardware.

• Provided compliance training.

• FDA readiness audit for Bio-Tech company (Israel).

• Guidance on interpretation and implementation of cGMP.

• Development of life cycle templates and documents based on criticality and complexity to meet

FDA requirements.

• Reviewed and evaluated client-generated documents used for submission to USFDA.

• Developed audit procedures.

5/95 – 6/98 TRS (Assigned to McNeil Pharmaceutical Consumer Products)

Senior Validation Specialist

• FDA-compliant validation of computer-controlled automated and semi-automated control systems

for the full range of pharmaceutical manufacturing facilities.

• Computerized Systems Validation (CSV), Process Validation, Supervisory Control And Data

Acquisition (SCADA), and Programmable Logic Controllers (PLC).

• Authored and supervised field execution of Installation Qualifications (IQ), Operational

Qualifications (OQ), and Process Qualifications (PQ) in a cGMP environment.

• Reviewed and modified vendor qualification protocols.

• Coordinated and supervised field execution of vendor validation activities.

4/92 – 5/95 Synerfac, Inc. (Assigned To Johnson & Johnson – Merck Pharmaceutical Products)

Instrumentation and Control Engineer

• Coordinated commissioning and startup activities for a new liquid and solids production plant.

• Authored and executed Factory Acceptance Tests (FAT) for process and packaging equipment.

• Authored PLC programs and operator interface programs using ControlView and WonderWare in

an FDA-regulated environment for: automatic batching, homogenizing, automatic weighing and

conveying, CIP (clean-in-place), pasteurization, high-speed rotary fillers, and labeling and

packaging.

• Operator interface programs consisted of P&ID screens, data logging, event-driven reporting,

trending, alarming, and preventive maintenance schedules.

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• Specified and selected instruments including control valves, flow meters, conductivity sensors,

density sensors, temperature, pressure, and level sensors.

• Authored and executed validation and qualification protocols for PLCs and SCADA, control

strategies, and plant process equipment.

• Coordinated, supervised, and debugged installation of equipment during plant start-up.

• Trained operators and technicians in proper operation, troubleshooting, and maintenance of plant

equipment.

9/91 – 4/92 Synerfac, Inc. (Assigned To Campbell Soup Company)

Instrumentation and Control Engineer

• Designed control systems and instrumentation for a pilot plant.

• Authored PLC programs for glass and can filling lines. Designed process control and

instrumentation systems for 300-jar washer and cooler, rotary fillers, and conveying systems.

• Specified instruments including modulating control valves, flow meters, pressure sensors,

temperature sensors, level sensors, and motion detectors.

3/91 – 9/91 H.L. Yoh, Inc. (Assigned to Day and Zimmerman, Inc.)

Instrumentation and Control Engineer

• Specified control systems and instrumentation for chemical plant expansion.

• Authored ISA specifications for over 600 field and in-line instruments.

• Consulted with clients to evaluate appropriate control schemes and type of instrumentation for

proper plant operation and cost effectiveness.

• Evaluated DCS systems and made recommendations to client.

• Coordinated process and mechanical data between company and client.

• Generated loop and I/O diagrams and installation details, and wrote scope of work.

3/90 – 3/91 Judge Technical Services (Assigned to Rorer Pharmaceutical Corp.)

Project Engineer – Instrumentation, Controls, and Automation

• Designed process instrumentation and control systems for pharmaceutical, liquid, and powder

production.

• Projects included: bulk storage, automatic dispensing and control of Sorbitol and aluminum

hydroxide, process air controls for drying of pharmaceutical powders to comply with FDA

requirements, tray drying, control of pharmaceutical powers, PLC control of granulating,

pneumatic conveying and milling of pharmaceutical powders, automatic dispensing of bulk

chemicals to water purification systems, conversion of existing systems from pneumatic to

electronic controls, interface of existing systems to the Honeywell TDC 3000 controller.

• Authored and executed IQs, OQs, and PQs.

• Wrote specifications and guidelines for instrument selection.

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Additional historical information available upon request.

References available upon request.

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