Experience

Kiniksa Pharmaceuticals

• United States
• Biotechnology Research
• 100 - 200 Employee

• Associate Director Supplier Quality Management

  • Jun 2022 - Present



Alnylam Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Quality Assurance Manager

  • Feb 2020 - Jun 2022

  •Ownership and Management Alnylam’s global GMP/GDP Audit and Supplier Qualification Program •Development and Implementation of Remote Audit program to ensure compliance during COVID-19 travel restrictions •Evaluation and Assignment of lead auditors for internal and external audits •Creation and maintenance of Audit Program annual budget •Coordinate and Perform Audits of GMP/GDP Vendors both as Lead Auditor and Co-Auditor •Led cross functional initiatives including expansion of… Show more •Ownership and Management Alnylam’s global GMP/GDP Audit and Supplier Qualification Program •Development and Implementation of Remote Audit program to ensure compliance during COVID-19 travel restrictions •Evaluation and Assignment of lead auditors for internal and external audits •Creation and maintenance of Audit Program annual budget •Coordinate and Perform Audits of GMP/GDP Vendors both as Lead Auditor and Co-Auditor •Led cross functional initiatives including expansion of Audit program to cover global requirements (e.g. ANVISA, EMEA, PMDA, etc.), and ensure scalability as Alnylam’s portfolio expands •Support site QA organization during regulatory and partner inspections •Coordinate with all internal GMP/GDP Alnylam stakeholders to ensure compliant and effective audits •Review and tracking audit reports, responses and CAPA •Collect, compile data for quarterly management review meeting. Schedule and manage meeting minutes and presentation

• Senior Quality Assurance Specialist

  • Dec 2017 - Feb 2020



Curia

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer, Team Lead

  • Oct 2015 - Aug 2017



Barry-Wehmiller Design Group

• United States
• Automation Machinery Manufacturing
• 700 & Above Employee

• Validation Engineer

  • Feb 2014 - Sep 2015

  Validation Engineer working for The Barry-Wehmiller Design Group. Contracted to Shire Human Genetics Therapies in Lexington MA as a Process Engineer. Managed change control for implementation of new autoclave cycles and load patterns developed under Engineering Test Plans. Changes included write up and approval of autoclave functional and configuration specifications, approval of impact assessments from various department, working with Shire automation engineering to implement PLC… Show more Validation Engineer working for The Barry-Wehmiller Design Group. Contracted to Shire Human Genetics Therapies in Lexington MA as a Process Engineer. Managed change control for implementation of new autoclave cycles and load patterns developed under Engineering Test Plans. Changes included write up and approval of autoclave functional and configuration specifications, approval of impact assessments from various department, working with Shire automation engineering to implement PLC software updates, programming newly developed cycle parameters into autoclave, assist in revisions to manufacturing operational SOPs for autoclave, and review and approval of validation qualification protocols. Participate in Design Review and Risk Assessment and engineering change management activities for autoclaves as a part of the MSL program. Supported Validation and Engineering activities at Shire Lexington and Cambridge facilities by providing engineering review of validation and engineering documents, assisting in troubleshooting equipment issues which occurred during execution, acting as autoclave engineering SME during resolution of validation discrepancies, and approval of validation and engineering protocols. Performed engineering evaluation of existing autoclave program and assisted in creation of new autoclave cycles and load patterns based on BS EN 285 Sterilisation – Steam Sterilisers – Large Sterilisers and Shire manufacturing needs. Development process included evaluation of load item materials of construction structure for potential challenges to steam penetration and air removal, temperature and lethality data analysis to ensure item sterility, design and fabrication of new autoclave spacers and load probe holders, and write-up, execution, and close-out of Engineering test plans.

• Validation Engineer

  • Mar 2013 - Feb 2014

  Validation Engineer working for The Barry-Wehmiller Design Group. Contracted to Citra Labs in Braintree MA as a Validation Engineer. Performed investigation, write up and execution for multiple CAPAs generated based on FDA observations and internal audit findings. Execution of these CAPAs required SOP review and revision, Preventative Maintenance review and revision, and evaluation of Quality Control and Production sampling methodologies. Developed cycles for Formulation Tank… Show more Validation Engineer working for The Barry-Wehmiller Design Group. Contracted to Citra Labs in Braintree MA as a Validation Engineer. Performed investigation, write up and execution for multiple CAPAs generated based on FDA observations and internal audit findings. Execution of these CAPAs required SOP review and revision, Preventative Maintenance review and revision, and evaluation of Quality Control and Production sampling methodologies. Developed cycles for Formulation Tank SIP, product formulation, Liquid load autoclave sterilization, and wrapped goods autoclave sterilization. Developed user requirement specification for filtered compressed air system to augment existing filtered compressed air system. Upon completion of URS, negotiated with vendor to ensure client’s needs were met by the new system. Supervised and coordinated Quality Control sampling of clean utility systems (Clean steam and filtered compressed air) for engineering studies and qualification protocols. Performed a variety of commissioning and qualification activities for equipment and clean room suite modifications related to FDA audit remediation. Effort included SOP development for and qualification (IQ/OQ/PQ) of a formulation tank, autoclave, and filtered compressed air system. Qualification activities for the autoclave included the revalidation of liquid product terminal sterilization, as well as the creation of two wrapped goods dry sterilization cycles for use by the Quality Control Lab and Production operators. Upon completion of SOP development, trained production operators, maintenance techs and quality control lab techs on the operation, cleaning, and maintenance of these systems. Participated in root cause analysis to investigate inadequacies in product terminal sterilization process identified during autoclave requalification efforts.



The Fountain Group

• United States
• Staffing and Recruiting
• 200 - 300 Employee

• Validation Engineer I

  • Jul 2011 - Dec 2012

  Validation Engineer I contractor working for The Fountain Group. Contracted to Abbott Bioresearch Center in Worcester MA as a Validation Engineer. Primary responsibly included writing, executing and closing validation protocols. The protocols included IQs, OQs, PQs, change over and periodic validation reviews. The protocols also included procedures such as SIP, CIP, temperature mapping, cleaning validation, P&ID review and standard operating procedure (SOP) review and edit. Protocols… Show more Validation Engineer I contractor working for The Fountain Group. Contracted to Abbott Bioresearch Center in Worcester MA as a Validation Engineer. Primary responsibly included writing, executing and closing validation protocols. The protocols included IQs, OQs, PQs, change over and periodic validation reviews. The protocols also included procedures such as SIP, CIP, temperature mapping, cleaning validation, P&ID review and standard operating procedure (SOP) review and edit. Protocols were executed on the following systems; bioreactors, mobile tanks, viral filtration carts, filter housings, cold rooms, incubators, freezers and autoclaves. Projects were performed in a cGPM facility. Show less Validation Engineer I contractor working for The Fountain Group. Contracted to Abbott Bioresearch Center in Worcester MA as a Validation Engineer. Primary responsibly included writing, executing and closing validation protocols. The protocols included IQs, OQs, PQs, change over and periodic validation reviews. The protocols also included procedures such as SIP, CIP, temperature mapping, cleaning validation, P&ID review and standard operating procedure (SOP) review and edit. Protocols… Show more Validation Engineer I contractor working for The Fountain Group. Contracted to Abbott Bioresearch Center in Worcester MA as a Validation Engineer. Primary responsibly included writing, executing and closing validation protocols. The protocols included IQs, OQs, PQs, change over and periodic validation reviews. The protocols also included procedures such as SIP, CIP, temperature mapping, cleaning validation, P&ID review and standard operating procedure (SOP) review and edit. Protocols were executed on the following systems; bioreactors, mobile tanks, viral filtration carts, filter housings, cold rooms, incubators, freezers and autoclaves. Projects were performed in a cGPM facility. Show less