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SUMMARY:

More than 25 years’ experience in validation worldwide medical-device/pharma/biotech.

Senior team lead of Large greenfield/ brownfield new construction.

15-years A&E/CQV firms. Developed the “integrated approach” which takes credit for all construction, commissioning, FAT and SAT testing.

Senior Validation Manager for multi-billion-dollar drug company.

Medical Device inventor, fabrication, Design Qualification, marketing focus groups, launch. The medical lifecycle is subject to 21-CFR-820, ISO-13485, ISO-14971 and IEC 62304.

Project Manager-proficient in Microsoft Project (Level-III schedules). Dashboards presented weekly.

ISPE Baseline Guide author and lecturer (risk approach to Packaging and Warehousing).

Lecturer on Change Control (sponsored by Barnett).

Cleaning validation of fill/finish production line sharing 40-potent compounds.

Complex protocols involving fractional DOE, statistical process controls, statistics of low and near-zero bioburden, always anchored in ISO, PDA, ISPE, WHO, USP and available foreign guides.

Certified Investigator of CAPAs. Expert in Risk Assessments models (FMEA and HACCP).

Advanced data analysis of Temperature Mapping.

Machine Learning and Vision Systems-“white/grey/black zones”. Preparation of “limit samples”.

Expert all forms of sterilization validation: wet/dry heat, gamma, electron-beam, ethylene-oxide.

Bowie Dick and appropriate use of chemical indicators (level 1,2,3 and 4).

Qualification: Facility/BMS, EMS, Clean Utilities, Medical Gas, Equipment, Instruments packaging, and Process Validation. Defect AQL.

Filter validation, bar-codes readers, vision systems, certification of visual inspection.

CSV SCADA/PLC 10,000 I/O points validation (white-box IS-88 architecture) per the IEEE Standard.

Seven (7) years’ experience as a validation manager for a large pharmaceutical firm.

Worldwide senior project lead-LVP, Vaccines, Isolator fill-lines, blow-fill-seal validation.

SKILLS:

15-years Design/Build/Construction/CQV pharmaceutical Greenfield and Brownfield sites.

10-years R&D New Medical Device Design/Development and Design Qualification and Validation

7-years Validation Manager for Aseptic/Fill-Finish-Packaging site.

2-years Quality Assurance Manager (Design quality, Construction quality).

Detailed Bulk Vaccine Validation Master Plan Wyeth Pearl River NY-best in class

Detailed Bulk/Finish Validation Master Plan Brazil Rio-de Janeiro every single setpoint included.

Detailed Bulk viral vector Validation Master Plan Kalivi PA-Single-Use-Systems (SUS) per PD 66

Detailed QC Lab Validation Master Plan Akorn NJ-every instrument and equip. per U

CSV GAMP Computer System Validation, Record-classification, Part-11 (Y/N) Network Data Integrity (record static or dynamic data migration from origin to archive/retrieval).

Cleanroom Qualification per ISO-14644 cleanroom OQ/ requalification per ISO-14644 (1-10)

Environmental Monitoring Performance Qualification (EMPQ) per PDA-13

Aseptic processing, semi-annual media-fills, Smoke studies (unidirectional flow pattern).

Risk Assessment Expert: Failure Mode and Effect Analysis (FMEA) and Hazard Analysis Critical Control Points (HACCP).

FAT, SAT, Commissioning (Cx), Installation, Operational, and Performance Qualification. Where possible we use “the Integrated Approach” which takes credit for testing done in FAT, SAT, CM, and Cx (when witnessed by validation or QC). ISPE endorse this approach as well as most corporate engineering and CAPEX sponsors, because “it buys down risk” to the project backend which can easily spiral out of control.

Commissioning and Qualification Checklists for every GMP system. Standard and optional tests listed with a checkboxes to customize level of test rigor the customer wants..

Mentoring/ coaching juniors/ no-experienced teams-tailored to their assignments using my extensive library and training materials over the years.

EDUCATION:

Bucknell University, Lewisburg PA, BSCHE Chemical Engineering/Biochemistry Minor

Columbia University, New York, General studies in Graduate School Neurobiology

Fairleigh Dickinson University-Madison NJ-MBA in Pharmaceutical Studies (Incomplete)

RECOGNITIONS/ CERTIFICATIONS:

Fundamentals of Engineering Exam Certificate awarded by Commonwealth of Pennsylvania Department of State Bureau Registration, Apr 16, 1988

ISPE Author Baseline Guide Packaging and Warehouse

Certified Investigator for Corrective Action and Preventative Assurance (CAPA)

Indoor Air Quality Technician 53926B52C51CADF70

HVAV Technicians Certification EPA Clean Air Section 608 84440EE0EF3E1ADF70

Member of Parenteral Drug Association (PDA), ISPE, American Society of Mechanical Engineers (ASME) and contributor to the ASME piping/ sanitary surfaces Bioprocess Equipment (BPE) Standard.

EXPERIENCE:

Akorn Pharmaceuticals Somerset NJ (Sept/2014 to Aug 2022)

Senior Validation Lead/ Validation Manager

Akorn is a large pharmaceutical firm with sites world-wide. At Somerset NJ they aseptic’fill/finish/package eyedrops and eye creams. The company closed down due to cash-flow issues in Aug 2022 & Feb 2023.

My responsibilities were:

Ten direct reports plus contractors.

Detailed Validation Master Plans (VMP).

Cleaning validation 44 product.

Sterilization (wet and dry heat, radiation, and ethylene oxide).

New Product Introduction.

Aseptic Operations.

Environmental Monitoring Performance Qualification (EMPQ).

ISO-41446 (1-10) cleanroom qualification.

Advance Statical control of repetitive operations.

Part-11 Electronic Records validation & betwork Data Integrity-electronic records must be classified and “static” or “dynamic” based upon what is retained.

Clean Utilities and automated system.

Medical Devices (6 years) in R&D I invent, focus group, market, write 510(k) and meet with FDA to determine jurisdiction. Unlike drugs, devices must be designed verified (DQ) to be “fit for use”. The Design Qualification is governed by 21-CFR 820, ISO-13485, ISO 14971, and IEC 62304. FDA and EU have different approaches. The Notified Bodies in the EU evaluate the application and award the “CE” status to sell. Annex 11 guides the software requirements. FDA CDRH evaluates/approves the 510(k) in the US and has different software standards.

J&J (McNeal) Lancaster PA (Dec-2012 to Aug-2014)

Consent Decree Project Manager (3 projects-CQV, Engineering Drawings, Packaging)

J&J McNeil is a consumer products company under FDA consent decree which required 3rd party oversight. This site made Tylenol, Pepcid, gels, and tablets.

My responsibilities were:

Project Manager of three consent decree projects; Commissioning and Qualification CQV), Drawings Remediation, and Packaging Validation Remediation.

oDevelop level-2 schedules with weekly dashboard progress reports.

oExecution of PPQ Pepcid Packaging Lines.

oRemediation of QC Lab qualification equipment.

Integrated Project Services (IPS) Merck West Point PA (Jun-2011 to Oct-2012)

Senior Validation Manager

IPS is a medium size design/build construction firm serving the pharmaceutical industry.

Each of these provide stand-alone and/or integrated validation services tailored to the clients’ requirements.

My responsibilities were:

Five direct reports

Market development at Merck West Point PA.

Support IPS Construction by providing validation services.

Convert West Point from tradition validation to “Merck Global Engineering Integrated Approach.”

Jacobs Engineering Conshohocken PA (Dec-1999-2007)

Validation Manager

Jacobs is the largest pharma design/build/validate Company in the USA. I supported the design/build process by providing validation services to the client.

My responsibilities were:

Ten to twenty direct reports

Support and estimate validation hours for new work.

Review client validation procedures and expectations

Assign qualification protocols and instruct each on the tests, test names, and execution approach.

Review and approve protocols and reports.

Manage budgets.

Schering Plough Summit NJ (11/2006 to 3/2009)

Quality Assurance Manager (Pharma Construction Quality-Campus Conversion)

Schering purchased the Summit NJ site and began a billion-dollar project to renovate the building and to add a full-scale Clinical Trials OSD facility. Other projects were QA/QC of new packaging garage, cafeteria, new Administrative building, and retrofit of the remaining existing buildings. The clinical trials facility was a modular construction in Sweden. Schering hire me through my company to be the Project Assurance Manager reporting to Schering’s VP of Quality for these construction projects. (It was my idea to purchase industry standard forms for each trade and my responsibility to obtain them).

My responsibilities were:

Write the site Project Quality Plan.

Research and procure the “best in class” documentation practices from each of the construction trade societies (concrete, painting, welding, expected testing & forms, sprinkler fire-code, electrical outlet labelling, cafeteria “burn-in”, doors open to inside, Turn Over Packages (TOP), write QA/QC SOPs for construction firm (Skanska), and required commissioning tests.

Validation Agents Inc. (Wyeth Pearl River NY) (5/2005 to 2/2006) My Consulting Company

Senior Validation Consultant

Validation Agents Inc. is my own company for consulting or standard alone contracts. Wyeth is a large pharmaceutical/ biotech firm. In 1996 Kvaerner John Brown built and validated Bldg. 211 bulk vaccine facility the blockbuster drug Prevnar -a multivalent pneumococcal vaccine). I was the lead validation for the initial CQV five years earlier. Wyeth brought me back to perform the required “five-year periodic review” of all the validation documents, SOPs, batch records, to ensure they meet any new standards or FDA requirements. I reviewed and performed a gap assessment which the company used to update these documents. The process took me a year.

My responsibilities were:

reviewed the validation IQ/OQ/PQ/ SOPs and to current industry practices.

Recommend supplemental testing where required.

Kvaerner/John Brown (Bridgewater/Pearl River/Brazil/Sweden/France) (1995-1999)

Validation Lead (worldwide validation teams)

Kvaerner/John Brown is one of the largest pharma design/build companies in the world. I was a senior validation lead for $100k-$700k new construction.

Wyeth Pearl River NY bulk vaccine Prevnar 23 Bldg. 211.

Brazilian “mega campus” supplying vaccines to all South America (super-detailed VMP, SOPs),

Pharmacia, Uppsala Sweden, highly automated Parenteral expansion (10,000 I/O point SCADA IS88 architecture, Electronic Batch Records, Part-11, AGVs),

Merck Clermont Ferrand France Lyophilized antibiotic potent compound Isolator/Fill/Finish

My responsibilities were:

Write detailed Validation Master Plans (VMP) and Project Specific Validation Plans (VP).

Write Computer System Validation Plan.

Write Configuration Management Plan.

Lead validation field teams.

Train validation field teams (these 10 tests, these 10 test names, criteria, vendor contacts and information, etc.)

Write IQ, OQ, PQs.

Write SOPs.

Manage man-hours/ budget. Track document progress.

Vital Signs Inc. Totowa NJ (1993-1995)

Senior R&D Engineer

Vital Signs is a $100-million Entrepreneur Medical Device Company. In Germany I developed a “collapsible container” with a nozzle filled with heparin and used to flush catheters. The novelty was no moving parts, a supple flexible color-coordinated container, formed and filled at the same time using Blow/Fill/Seal technology. In addition, since injecting bubbles is lethal, I designed an oversized cavity in the tab so the container could be overfilled into the tab. In addition, I successfully argued before FDA that my prefilled “plungerless syringe” should be classified as a device rather than a drug.

My responsibilities were:

Invent novel medical devices.

Perform Design Qualification on the device.

Perform qualification and validation on the equipment and production process.

Prepare the New Medical Device or generic equivalent 510(k) filing in US and EU.

Write detailed Validation Master Plans and Cleaning Validation Plans per PDA Technical Reports 29 and 49.

Becton Dickinson Co. Franklin Lakes NJ (1989-1993)

R&D Engineer

BD is the largest blood collection tube/ syringe manufacturer in the world. As an R&D Engineer I supported the development/ validation of product upgrades, application of cutting-edge new technology to the devices, and surveillance of emerging technology that might threaten the market share.

My responsibilities were:

Convert the glass blood collection tubes to plastic.

Plastic tubes lose vacuum. So, I developed/patented a barrier composite transparent label that overwrapped the tube prolonging shelf-life.

Validate tube filling of very small fill volumes using an extended setup and Statical Process Controls.

Improved barrier properties by 3-D cold-vapor deposition with silica.

Technology threat surveillance screening patents and industry trade journals.

Developed/patent anti-HIV cocktail additive for tubes to protect phlebotomist.

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