SUMMARY: 

17years combined experience in Validation for the Biotech/Pharmaceutical industries with an additional 5 years as an Analytical Scientist in the Pharmaceutical Industry. Validation experience includes: Laboratory, Manufacturing, Utility/Support Systems Qualification, Process and Method Validation.

MAJOR RESPONSIBILITIES:

• Validation Manager
• Project Lead
• Clean Utilities Lead
• Quality Assurance/ Quality Engineer Specialist
• Validation Technical Consultant
• Commissioning & Design Qualification Lead
• Analytical Scientist

VALIDATION POSITIONS:

Validation Contractor

Confidential, MA 

• Responsible for supporting the RDSQO Validation Department
• Responsible for supporting the 45NYA Facilities Department
• Responsible for supporting the 68NYA Laboratory Equipment Qualification Project
• Statistical data analysis.
• Drafting, execution and approving Validation Project Plans, Protocols and Final Reports.

Validation Contractor

Confidential, MA

• Responsible for the development of equipment and utilities validation protocols
• Coordinate validation activities with manufacturing and engineering.
• Collected and analyzed statistical data.
• Initiated CAPAs, investigated and assisted deviation closeouts and.
• Drafting and routing summary reports.

Project Consultant

Confidential, MA

• Responsible for remediation and closure of Backlog Change Controls, Deviations, and Corrective Action/Preventive Actions
• Preparation and execution of Validation Protocols, Change Qualifications, Changeover Qualifications, Sterile Hold Qualifications, Cleaning Verifications

QA Validation Consultant

Confidential, MA

• Responsible for the review and approval of QC Analytical Methods based on ICH guidelines,
• Verifying and approving MACO (Maximum Allowed Carry Over) calculations to determine CIP acceptance criteria
• Responsible for maintaining the sites Validation Database
• Disposition and approval of Validation Protocols and Change Requests
• Review and Approval of Validation Deviations and Investigations
• Developing a quarterly review of all GMP impacting HVAC systems

CQV Clean Utility Lead

Confidential, MA 

• Performed/Assisted the Commissioning/Verification of the following Clean Utility Systems: Soft Water, Carbon Beds, WFI stills, WFI Storage and Distribution, Acid Caustic Tanks and Distribution, Biowaste, LN2, O2/CO2/Clean Air.
• Developed/Authored Confidential LSCC Installation / Operational Verification (IOV) Protocols.
• Facilitated construction completion activities and Punchlist closure.
• Executed system walk downs and relined P&IDs.
• Scheduled, coordinated and executed Commissioning Installation and Operational Verification activities.
• Responsible for the initiation and resolution of exceptions/deviations.
• Assisted Turn Over package completion.
• Reviewed testing and system support documentation: (Mfg/vendor, construction, engineering, automation and calibration).
• Responsible for assisting the completion and approval of the Commissioning Installation/Operational Verification protocols.

Validation Engineer

Confidential, MA

• Responsible for the Installation and Operational Qualification of the 50L and 500L Bioreactors (R1,R2 and R3).
• Responsible for the Performance Qualification of the 50L and 500L Bioreactors (R1,R2 and R3).
• Responsible for Qualifying the Bioreactors Control System and Data Historian (SCADA/Invensis: Wonderware).
• Responsible for Qualifying the QA Document Control Database.
• Responsible for Qualifying the Clean Steam System.

Quality Consultant, Auditor

Confidential - N. Billerica, MA

• Conducted a quality review of all HVAC system; validation, engineering and certification documentation.
• Performed a quality assessment on the system’s status based on cGMP’s, regulatory filings, product/process impact, production and manufacturing requirements, and internal quality documentation.
• Developed an Assessment Report and Proposal for the facilities HVAC system.
• Provided guidance on a System Impact Assessment model and on the generation of a Site Validation Master Plan.

Quality Engineer, Validation Project Manager

Confidential - Cambridge MA

• Responsible for the review and approval of control software and automation test documentation
• Review and approval of critical work orders, change requests, deviations, and error logs related to control software, automation, process equipment, and controlled temperature equipment
• Assisted in the creation and implementation of Global Procedures and SOPs related to control software and automation
• Risk Assessment of site utilities including Water Systems, HVAC, and Clean Steam
• Impact assessment of automation changes to equipment using site change control procedures
• Philosophy / process improvements for automation and equipment validation processes
• Protocol review and approval for controlled temperature equipment, autoclaves, cleaning validation, and utilities
• Execution of validation protocols for incubators, freezers, and environmental chambers
• Troubleshooting and deviation resolution for temperature controlled equipment

Validation Project Manager 

• Responsible for cost assessments, budget analysis, project scheduling and turnover.
• Created a Validation Project Metrics Database.
• Reviewed and Approved Validation protocols.
• Coordinate floor validation activities.
• Collected and analyzed validation data.
• Initiated, investigated and assisted closure of Deviations.
• Performed GAP analysis and conducted quality audits on Laboratory and Manufacturing equipment.
• Collaborated with Engineers to troubleshoot system failures.
• Drafted Qualification Final Reports.

Validation Project Lead

Confidential - West Greenwich, RI

• Responsible for protocol development and execution of SIP protocols for manufacturing and preparation areas.
• Coordinate SIP floor validation activities with manufacturing and engineering.
• Collected and analyze SIP-DCS reports and statistical data.
• Initiated, investigated and assisted SIP closures of Non Conformances.
• Drafted and approved SIP Qualification Final Reports.
• Re-qualified HVAC System for manufacturing suite build out.

PROFESSIONAL EXPERIENCE: 

Validation Manager/Validation Lead

Confidential, Portsmouth, NH

Primarily responsible for managing the Validation activities at Confidential (Large Scale Built Out) which included the development, generation and execution of validation policies and protocols: QC Laboratories analytical and support equipment, Inoculum equipment/ support utilities qualification, CIP (new production and support systems), Operationally Qualified all Fermentation systems and skids (including SIP Validation).

• Manager of Laboratory Validation: Responsibilities included the authoring of Philosophy documents, Master Plans, position papers and overseeing the generation and execution of all QC Laboratory Analytical and Support instrumentation/equipment. Qualified the Utility Systems required for the Laboratory Areas.
• Inoculum Prep Lead: Drafted and executed Inoculum equipment protocols, including Wave S200 and S20 Bioreactors, Cryo vessels, Incubators, freezers, refrigerators and Roller Bottle apparatus. Configured and qualified the system interfaces to the DCS and BAS systems. Set up and qualified the Utility Systems required for the Inoculum Prep Areas.
• Clean in Place Lead: Buffer/Media/Fermentation/Harvest and Purification. Responsible for the generation of all CIP protocols. Additionally responsible for development of Confidential CIP Validation Master Plan and Process Validation program.
• Utility Systems Lead: Assisted the development and generation of Utility System protocols including, Gas Distribution and HVAC/HEPA Controlled Spaces, and WFI and Purified Water Systems. Additionally responsible for overseeing the compliance to regulatory and industry standards.

Manager of Validation & Chemistry

Confidential

Primary responsibilities include the generation and execution of validation protocols for Biotechnology and Pharmaceutical clients, specializing in process equipment, instrumentation and medical devices.

• IQ, OQ, PQ development and execution, Quality System (QA/QC) auditing and consulting, process development, technical support and service.
• Validation training and development of client Quality Systems.
• Sales, marketing, equipment servicing.

ANALYTICAL SCIENTIST POSITIONSConfidential

Analytical Scientist

• Responsible for analytical method development/validation, instrument validation and report/ method writing.
• Conducted product investigations and routine analytical testing.
• Internal cGMP/GLP and Quality Assurance Laboratory Auditor.
• Responsible for routine instrument/equipment service and maintenance.

Confidential

Analytical Chemist

• Responsible for method development/validation as well as stability and quality control testing of Topical Drugs and Cosmetics using HPLC, GC and UV. Other duties included: Laboratory Safety Officer, Instrumentation trainer and Internal Laboratory Auditor.