James Ryan

Results-driven manufacturing and validation engineer with over 6 years of biotech experience spanning equipment qualification, process engineering, cGMP compliance, and continuous improvement. Proven track record leading IQ/OQ/PQ programs, developing and standardizing SOPs, and driving Lean/Kaizen initiatives that improve safety, quality, and efficiency. Skilled cross-functional collaborator with hands-on expertise in SolidWorks, thermal mapping systems, and regulated manufacturing environments.

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.

Master of Science - Engineering Management - Northeastern University (2017-05)

Bachelor of Science - Mechanical Engineering - Northeastern University (2015-05)