Validation Engineer II - Organogenesis - Canton, MA
(2023-10 - 2026-03)
- Led qualification of KAYE AVS thermal mapping systems, authoring full IQ/OQ/PQ protocols and validation summary reports in compliance with cGMP requirements.
- Owned site-wide equipment requalification program covering controlled temperature units, autoclaves, and environmental monitoring systems, ensuring zero lapses in qualification status.
- Served as technical assistant for new Providence, RI facility commissioning, coordinating IQ/OQ/PQ execution across multiple equipment types and resolving non-conformances to meet project milestones.
- Mentored junior validation staff on data logger operation, KAYE AVS workflows, and documentation best practices, improving team efficiency and consistency.
- Partnered with cross-functional teams including Quality, Manufacturing, and Facilities to schedule and execute requalification activities with minimal disruption to production.
Operations Engineer - Azzur Cleanrooms on Demand, LLC - Burlington, MA
(2021-01 - 2023-09)
- Developed and executed IOPQ protocols for new cleanroom equipment, ensuring readiness for cGMP operations and on-time delivery for client programs.
- Managed proactive requalification scheduling for all in-use equipment, maintaining continuous cGMP compliance and reducing unplanned qualification failures.
- Served as primary technical point of contact for environmental monitoring systems, diagnosing and resolving equipment alarms to protect product quality and facility integrity.
- Collaborated with clients and internal stakeholders to assess equipment qualification status, prioritize workloads, and communicate progress against milestones.
Manufacturing Engineer - Metso - Shrewsbury, MA
(2019-02 - 2020-04)
- Standardized assembly and testing SOPs for multiple product lines through structured cross-functional collaboration with production, maintenance, and quality teams, reducing variability and improving throughput.
- Designed ergonomic assembly tooling in SolidWorks that enforced safety limits and reduced cycle times, demonstrating direct impact on both operator safety and production efficiency.
- Led a Kaizen event to redesign shop floor tool organization and deploy visual management standards facility-wide, improving 5S compliance and reducing tool search time.
- Partnered with quality and maintenance teams to identify root causes of assembly defects, implementing corrective actions that reduced rework rates.
Engineering Co-op - Solidscape - Merrimack, NH
(2014-07 - 2014-12)
- Designed and prototyped fixtures for 3D printing systems in SolidWorks, supporting functional testing and accelerating product development cycles.
- Engineered replacement components ensuring dimensional compatibility with existing assemblies; revised legacy part designs to meet updated engineering standards.
Manufacturing Co-op - Genzyme Corporation - Allston, MA
(2013-07 - 2013-12)
- Coordinated equipment installation and commissioning for a new manufacturing suite, supporting facility readiness and production launch activities.
- Performed functional testing on new equipment including a Tangential Flow Filtration system, documenting results to support qualification and regulatory submissions.
- Reviewed and updated Lean manufacturing documentation and SOPs, incorporating safety revisions and ensuring alignment with current operational standards.
Endoscopy Design Quality Assurance Co-op - Boston Scientific - Marlborough, MA
(2012-07 - 2012-12)
- Executed mechanical performance testing on endoscopic devices including the RJ4 Gold probe catheter using an Instron machine, verifying compliance with product specifications.
- Maintained quality traceability by documenting and communicating test results through the Product Documentation Management (PDM) system.
- Revised product procedures and safety documentation for endoscopic product lines, ensuring regulatory and design compliance.
