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Pharmaceutical Validation Consultant

Wake Forest, North Carolina, 27587, United States
May 22, 2018

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Randy Polacsek

Wake Forest, NC


Qualifications Summary:

Senior Engineer experienced in delivering cGMP Life Science projects. Process and hands-on experience and knowledge of pharmaceutical manufacturing equipment including automation, packaging and laboratory systems provides strong competence to deliver and execute Engineering, CQV (Commissioning, Qualification, Verification), and QMS (Quality Management System) projects. Successfully implemented equipment, systems, and projects at pharmaceutical, biotech, device, and contract research and manufacturing sites over a period of 15 years. As a collaborative and individual contributor, communicated, coordinated and delivered systems in cooperation with project teams from Technology, Manufacturing, Automation, and Quality.

Projects (2013-2018):

●Pfizer: Serialization system, new device packaging line equipment and serialization system delivery, Systech, Rockwell, Allen Bradley, responsible for development of User Requirements, Engineering specifications, Commissioning and Qualification protocols development and execution, Missouri (2017-2018)

●Shire Baxter: CIP/SIP process, Siemens MES Commissioning, provided dry run test execution of cleaning and sterilization MES processes, Georgia (2016/2017)

●Banner Patheon: Autoclave(s) calibration, Kaye 2000, responsible for autoclave calibrations using industry standard Kaye, NC (2016)

●GSK: Serialization inhaler device packaging line IOQ, Systech, Rockwell and Siemens. Inhaler packaging line vision inspection device, responsible for equipment qualification and implementation, NC (2015/2016)

●Fuji-Diosynth: Bioreactor mammalian cell growth train, Rockwell, ABB DCS, Wonderware, responsible for developing the integrated automation system’s batch phase requirements, commissioning and qualification protocols, NC (2014-2015)

●Genzyme (MA), Merck (NC): Cell culture, vaccine, and stabilizer procedures, Werum PAS-X MES, responsible for MBR configuration, Design specification development, and development and dry runs and execution of qualification protocols (2013-2014)

Eli Lilly (IN) Aseptic insulin manufacturing and packaging (2003-2013)

●Utilizing Rockwell PMX MES,Developed MBR’s and associated EBR’s. Batches commissioned and qualified (FAT/SAT, IOPQ). Supported operations 24 hour floor support. Tested initial packaging Systech serialization stage. Supported initial development of Matrikon interface. Trackwise, Maximo, HP Quality Center

●9 years of Automation / Validation / Systems Engineer responsibility, including ABB and Rockwell systems development, implementation, qualification, and validation of S95/S88 PLC/DCS automation control systems in the pharmaceutical and chemical industries including DuPont, Kodak, Alkermes, Lilly, other. (1998-2007, 2014-2016)

Key Experience:

Validation: Rockwell, Siemens, Systech

MES Development and CQV of PMX and PASX

Process: Aseptic, Extraction, Centrifugation, Parenteral Fill and Finish, Packaging, Devices

S88 / S95 SDLC deliverables

Automation: RS Batch, ABB 800xA


Work Experience:

Independent /W2

Consulting Engineer

Wake Forest, NC

●Projects above and related QMS


MES Engineer

Raleigh, NC

●MBR development, OQ protocol development and execution, QMS (SDLC) documentation, Design Reviews, Werum’s PASX MES (Merck, NC and Genzyme MA)

Eli Lilly

Assoc. Info Consultant

Indianapolis, IN

Insulin MES Manufacturing Development/Stabilization/Maintenance

●Aseptic insulin processes; Parenteral Formulation, Vial Washing, Aseptic Filling, Automated Vision Inspection, Capping, Sorting, Equipment Preparation, SIP / CIP, and Autoclaves.

●Modeled, designed, tested, launched, stabilized, and supported MES Operations.

●Developed, configured and verified: equipment and material PFD’s, MBR specs, MES SOP’s, MES/automation interfaces, paper to electronic work instructions.

●Aseptic Formulation, Filling, CIP, SIP, Packaging, Devices

●Successful implementation of approximately 20 Parenteral MES MBR’s

●Serialization configuration, 2D barcode implementation project

●Packaging and DDAO represent 60 MBR's and 250 plus sustained MES EBR’s

Eli Lilly

Automation CSV Engineer

Manassas, VA

●Qualified a Rockwell automation development/test lab, developed/executed IOQ

●Created Automation Test Qualification package for stick-built code (unit, integration, system testing)

●S88: Control and Equipment Modules, Equipment Phases, Unit and System Level test protocols

●Site level risk based CSV Master Plan, QMS program, and Infrastructure Qualification Plan

●C&Q Plans for SCADA’s (formulation, sterile filtration, utility processes and building management)

Cetan Technologies

Automation CQV Engineer

Dayton, OH

●Automation and Validation engineer microsphere manufacturing, RS Batch, RS ControlLogix

●IQ, OQ, Sequence of Operation Test Scripts for Microsphere production (1500 I/O, 160 Phases)

●Developed unit module, graphic, alarm, and security scripts. FRS/DDS Reviews

ABB, CPI Division

Automation Engineer

Columbus, OH

●Parenteral and cell culture, CIP/SIP, distillation, flat sheet, coating ops

●Implemented, tested, and troubleshot, batch and continuous DCS’s

●Configuration and verification of a 3200 I/O database; included complex loops and interlock designs

●Configured multiple dual data historian systems

●C&Q field experience, Loop checks, IQ and OQ execution


Clarkson University BS Chemical Engineering

State Univ. of NY BS Chemistry

Professional Skills and Training

Licensed Professional Chemical Engineer, June 2002 State of Ohio, PE67087 (inactive 2016)

Continuing Education

2016 Automation Systems Training -Inductive University / Ignition SCADA (April 2016 –)

Automation and MES Training

EDB (Database) 2008

EQM (Equipment) 2008

EBR (e Batch Record) 2008

Werum PAS-X 2.0 (2013)

MBR Authoring (2008-13)

August 2013, Durham, NC

Werum PAS-X 2.0

PASX System Administrator

August 2013, Durham, NC

Process Control Systems Training (1997 - 2006)

Factory Talk Lab 2006

Logix 5000 Maintenance 2004

Rockwell Batch, AZ 2002

Microsoft Access 1998

AccuRay Smart Platform 1998

TCL Code 1997

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