Bernard Padin

Over 25 years of Pharmaceutical and Biotechnology Manufacturing Facilities CQV/CSV combined experience. Strong background in the development, generation, implementation, execution and maintenance of commissioning, qualification, validation and regulatory programs subject to evaluation or inspection by regulatory agencies of the United States FDA Regulations. Knowledge of USP, EP and JP Pharmacopoeia Guidelines.

An extensive background in Clean Utilities, Manufacturing Rooms Class ISO 5 to ISO 8 and BSL 3 Cleanrooms, Aseptic Filling Lines, Medical Grade Gas Systems (CCA, N2, C02, 02 & Mixed Gases), WFI, Clean/Pure Steam and USP Purified Water Generation and Distribution, Steam-in-Place (SIP), HVAC, Laboratory and Manufacturing Equipment, Packaging lines, Visual Inspection Systems, Autoclaves, Lyophilizers, Depyrogenation Tunnels, Isolators, CTU Temperature Mapping, Environmental Chambers, Incubators, Refrigerators, Freezers, Cryogenic Tanks, walk-in unit, warehouse and TCU. Also, extensive experience with CSV protocol generation and execution of many systems/equipment and/or process using PLC (Rockwell (Allen-Bradley), Siemens, ABB, etc.), SCADA (Bristol Babcock, Siemens, etc.), DSC (Emerson Delta V), OIT/HMI PanelView touchscreens, and stand-alone software and firmware applications.

Sr. Validation Engineer (Contractor) - Fujifilm diosynth BIOTECHNOLOGY - College Station, TX

(2024-07 - 2025-09)

Develop and execute IOQ and PQ Protocols for many areas including manufacturing autoclave, temperature mapping, laboratory benchtop equipment, utility/facility systems and Capital Projects. Route protocols for Pre/Post-Approval, close any discrepancies generated and generate final summary reports. Assist and support other CU systems (WFI, CS, RODI) in the development of URS, IOQ, RA, RTM.

Develop SQT SOP, Test Tables and execute SQT. Requalification and Periodic Review protocol executed in Kneat Validation Software and/or Veeva templates for freezers, incubators, etc. Provide validation assessments.

Perform clean utilities systems P&ID walkdowns. Follow company SOP (MasterControl, ComplianceWire, Veeva). Generate work request using BMRAM, closed work activities, send for review and approval.

• Generate and execute IOQ and PQ, Requalification and Periodic Review of critical systems
• Route qualification package for approvals
• Follow company procedures and policies
• Report CQV status via Smartsheet tracker and other spreadsheets

Sr. Validation Engineer (Contractor) - Fujifilm diosynth - Holly Springs, NC

(2024-01 - 2024-06)

Develop and execute commissioning IOV Protocols for the Clean Utilities manufacturing gas systems using Kneat Validation Software, assist and support other CU systems (WFI, CS, PurW) in the development of URS, VPP, DQ, QRA, IOQ, RTM, also support the Micro Lab team in the preparation/connections for gas sampling and develop initial gas start-up sampling plan. Perform systems walkdowns, identified gas systems specs discrepancies.

• Lead Clean Utilities Gas Systems (CCA, N2, O2 & CO2)
• Follow company procedures, policies and FujiFilm Denmark templates

Sr. Validation Engineer (Contractor) - Millipore sigma - Indianapolis, IN

(2023-11 - 2024-01)

Assist the validation team executing an IOQ Addendum protocols for a SKAN Isolator with an Aseptic Robotic Filling Line, Lyophilizer with autoloading/unloading and Stopper/Capper manufacturing Line.

• Execute and support IOQ activities
• Follow company procedures and policies

Sr. Validation Engineer (Contractor) - NorthStar Medical Radioisotopes - Beloit, WI

(2022-04 - 2023-05)

Assist Validation team developing CQV documentation for new and existing equipment and utilities at the Beloit, WI site. Generate commissioning and IOQ Protocols, Deviations and Summary Reports. Route CQV documents through the review and approval process in MasterControl. Assist other NorthStar sites Validation team reviewing CQV protocols and generating final summary reports.

• Generate and execute CQV activities
• Review and approve CQV documents
• Follow company procedures and policies

Senior Validation Engineer (Contractor) - Cognate/CRL - Memphis, TN

(2022-01 - 2022-04)

Assist Validation team developing CQV documentation for existing equipment and utilities at Memphis, TN site. Route CQV documents through the review and approval process in MasterControl.

• Generate and execute CQV activities including Validation Plans and User Requirements Specifications in efforts to bring the clinical facility to a commercial GMP level facility
• Follow company procedures and policies

QC Technical Writer (Contractor) - EMERGENT BIOSOLUTIONS - Bayview Baltimore, MD

(2021-07 - 2021-12)

• Generate Impact Assessments
• Generate Change Control Summary Reports for FDA review
• Follow company procedures and policies

Sr. CQV Engineer (Contractor) - Pfizer - Kalamazoo, MI

(2020-06 - 2021-07)

Develop Design Specification documents for the HVAC System, Aseptic Filling manufacturing lines and critical utilities (CS, WFI and CCA). Verification Test Protocols (Installation and Operational Protocols) and Performance Qualification Protocols generation using TrackWise, and execution protocol for aseptic filling, Lyophilizers and critical utilities.

• Execute commissioning VTs protocols
• Follow company procedures and policies

Sr. CQV Engineer (Contractor) - Kimberly-clark - Neenah, WI

(2019-12 - 2020-06)

Assembly and packaging line equipment transfer, Installation, Operational and Performance Qualification protocols generation and execution for the manufacturing packaging lines (Product Transfer Project and new added lines) for a Class 1 Medical Devices facility.

• Generate and execute IOQ/PQ protocols with CSV challenges on high speed packaging lines manufacturing process
• Assist client in the process of identifying pre-requisites and project deliverables to meet project objectives, scopes and deadlines
• Follow company procedures and policies

Sr. Facilities Manager - Captozyme - Gainesville, FL

(2018-05 - 2019-09)

Assist in preparation of the master plan around building security system and support the proper implementation, testing, training and maintenance of facility security and monitoring systems such as security and fire alarm systems and temperature monitoring systems. Work with the Director of Quality and the safety committee for the proper handling of waste and other facilities considerations of the environment and work environment. Contract qualified contractors for any new utilities or facility projects.

• Responsible for the leadership and organization facilities operations, including but not limited to: maintenance services, renovation and construction master plans, energy management, security management, and environmental management
• Also responsible for planning, implementation, maintenance and compliance of all mechanical (equipment), HVAC, metrology, and utilities proper operations in a GMP compliant and FDA regulated facility, including planning, design, continuous improvement of the facility and utilities, coordinating and managing all equipment and critical utilities qualifications and preventive maintenance, in close collaboration with the Quality Team
• Follow company procedures and policies

Sr. Validation Engineer - Ology Bioservices - Alachua, FL

(2015-09 - 2018-05)

Critical Utilities SME and RSO, Lead start-up, shakedowns, commissioning, qualification and validation of the critical utilities systems supporting all manufacturing areas, including BSL - 3 manufacturing rooms and laboratory areas.

• The responsibilities included assuring a successful vendor installation (start-up), systems certifications and field tests/inspections, SAT and com