Manufacturing & Process Engineer

ANNA HOWARD Manufacturing/Process Engineer

720-***-**** *************@*****.*** Watertown, MA linkedin.com/annahoward12 CAREER SUMMARY

Manufacturing and process engineer with 5+ years of experience developing scalable production systems and supporting product transfer from development to manufacturing in high-growth technology environments. Proven track record building data-driven manufacturing infrastructure, leading cross-functional process scale-up initiatives, and implementing automation that improves quality, throughput, and operational visibility. PROFESSIONAL EXPERIENCE

REAGENT MANUFACTURING ENGINEER Vizgen Waltham, MA Feb 2023 – Present

• Designed and deployed an automated manufacturing data pipeline to extract batch record data and monitor process performance using Statistical Process Control (SPC), enabling proactive identification of variation and improved real- time production visibility.

• Led cross-functional technical transfer of multiple NPIs from R&D to manufacturing, including equipment sourcing, raw material validation, process definition, and scale-up to production.

• Spearheaded implementation of automated label generation directly from batch records, eliminating a recurring nonconformance category and reducing manufacturing cycle time by 15%.

• Partnered with QC to implement QBench LIMS, streamlining sample submission workflows and result reporting.

• Led equipment relocation and requalification during manufacturing site expansion, ensuring production continuity and readiness for increased throughput.

• Authored and optimized manufacturing documentation including BOMs, SOPs, batch records, and cost models to support process robustness, scalability, and regulatory readiness.

• Led supplier qualification and risk assessments for outsourcing of a key product line, mitigating supply risk while ensuring continuity, and completing transition ahead of schedule.

• Provided hands-on engineering support in a cGMP environment, leading root cause investigations for process deviations and authoring nonconformance documentation as well as CAPAs to drive systemic corrections.

• Owned equipment lifecycle management for production systems, including custom automation platforms and Hamilton liquid handlers, ensuring calibration, validation, and operational readiness. PRODUCTION GROUP LEAD, BUFFERS Vizgen Waltham, MA March 2020 – Jan 2023

• Led and developed a team of 12 manufacturing associates in a rapidly scaling regulated production environment.

• Designed and managed dynamic production schedules to support commercial demand and R&D pipeline needs.

• Implemented Lean manufacturing improvements in collaboration with engineering and operations teams, increasing production throughput and reducing workflow inefficiencies.

• Authored SOPs, work instructions, and batch records to improve clarity, compliance, and operator efficiency. EARLIER EXPERIENCE

CLINICAL TRIAL SUPPORT Damiano Lab at Boston University Boston, MA 2020

• Supported clinical trials for a wearable bionic pancreas for automated insulin delivery in patients with Type 1 diabetes.

• Assisted with device preparation, data collection, and participant monitoring during clinical studies evaluating real- world performance of the wearable medical device system. MANUFACTURING OPERATIONS INTERN – SURGICAL INNOVATIONS Medtronic Boulder, CO 2018

• Supported high-volume manufacturing of electrosurgical medical devices, working with production teams to maintain throughput and quality in a regulated manufacturing environment.

• Assisted with fixture design and production line improvements to support consistent device assembly and testing. EDUCATION

SIX SIGMA GREEN BELT Boston University Metropolitan College 2025 BACHELOR OF SCIENCE Biomedical Engineering Boston University 2020 SKILLS & EXPERTISE

Manufacturing Process Development New Product Introduction Process Scale-Up Automation & Data Systems Statistical Process Control Root Cause Analysis Cross-Functional Engineering Collaboration Supplier Qualification Lean & Six Sigma

Python Minitab QBench LIMS NetSuite Arena PLM Equipment Qualification (IQ/OQ/PQ) Technical Documentation

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