Process Development Engineer & Project Management Expert

1. Leak Test Process Limit Re-evaluation

Duration: November 2020 - June 2021

Scope: Lines 1, 2, & 3 - All Station 45MM leak testers

Problem: Most in-line leak test failures were false positives - system failures at tester seals rather than actual part defects.

Solution: Conducted comprehensive data analysis, re-evaluated process limits based on actual failure modes.

Results: Significantly reduced false reject scrap and improved overall throughput.

2. Reduction of Tipping Cycle Time

Duration: December 2020 - June 2021

Problem: Production rate below 6 PPM target. Cooling time on tipping station identified as bottleneck.

Results: Saved 1 second per part cycle time, increased throughput across all lines.

3. Robot Unload Swap Nest Fault Reduction

Duration: July 2020 - June 2021

Results: Increased MTBF (Mean Time Between Failures) by 3,158 units, reduced scrap by 3,294 units.

4. Plug Concentricity Reduction

Duration: March 2021 - June 2021

Results: Reduced false rejects, improved throughput, established offline validation protocol.

Primary Objective

Drive rapid process improvement on P&I Encapsulation Systems at Boston CMC site to enhance manufacturing performance robustness for the VX-264 Ph1/2 Study (Part C)

Deliverable Target

Deliver N=5 reliable GMP systems (2x in-suite + 2x Lab + 1 spare) at Boston CMC site operations prior to the start of Part C clinical trials

Knowledge Transfer

Transfer learnings, actions, and improvements to Ph3 and biotech commercial equipment integrators

1. Layout Owner: Sushan (Co-lead)

Goal: Improve workplace efficiency and productivity by creating a clean, organized, and safe work environment.

• 5S the room for materials and tools needed
• Label all lines to match drawings and SOPs

2. Maintenance Owner: Sushan (Co-lead)

Goal: Reduce likelihood and impact of equipment breakdowns and part stock outs.

• Review CM history to update PM plans for all equipment
• Formalize / expand troubleshooting guide
• Analysis of critical part spares, shelf lives, and stock quantities

3. Manufacturing Owner: Sushan

Goal: Improve execution and visibility of manufacturing performance.

• Investigate simplification of MBR
• Implement downtime tracker to track/trend equipment failures
• Track and trend pass/fail data (in progress)

4. Final Seal Owner: Sushan

Goal: Provide clarity to the floor on how to successfully execute final seal glue and associated pass/fail criteria.

• Evaluate option of updating QC release criteria to allow microbubbles
• Train operations personnel
• Develop guidance for operations for addressing bubbles in glue
• Refine purge process for glue dispense to mitigate bubbles
• Implement UV wand calibration tool
• Evaluate methods to improve visibility during final seal

1. Syringe Tip & Adhesive Dispensing Optimization

Objective: Enhance sealing precision and eliminate adhesive defects in encapsulated devices.

Actions:

• Designed DOE studies on tip inner diameter, dispensing pressure, and adhesive viscosity
• Performed temperature-dependent viscosity profiling for the two-part epoxy
• Collaborated with suppliers to develop a custom stainless-steel tip with anti-wicking geometry
• Introduced automated volume verification for 100 µL adhesive dispenses

Impact:

• Completely eliminated the "bubble" defect observed during optical inspection
• Achieved ±5% adhesive-volume accuracy across all devices
• Improved long-term mechanical strength and seal durability

2. Final Seal Quality Event (QE) Investigations

Objective: Resolve recurring Out-of-Specification (OOS) seal integrity failures during patient fill runs.

Scope & Actions:

• Led multi-departmental investigations (Process Development, Quality, and Operations)
• Conducted viscosity degradation studies, rheology modeling, and seal tensile tests
• Identified humidity sensitivity and temperature variance as root causes
• Defined new viscosity acceptance limits, operator retraining, and adhesive mixing validation
• Updated FMEA, work instructions, and failure modes

Impact:

• Closed six major Quality Events (QEs)
• Prevented recurrence across subsequent runs
• Improved lot-release rates and enabled uninterrupted patient fills

3. Automation and Equipment Integration (NPI Phase)

Objective: Transition manual pilot processes into semi-automated encapsulation and sealing workflows.

Actions:

• Defined equipment URS for encapsulation modules, adhesive dispensers, and leak testers
• Partnered with automation vendors to develop modular control logic for scalable deployment
• Conducted line balancing and OEE analyses to determine optimal operator allocation
• Oversaw FAT/SAT and commissioning activities

Impact:

• Doubled production throughput with reduced operator fatigue
• Established baseline for future full automation
• Supported seamless tech transfer to pilot and manufacturing facilities

4. Process Characterization and Validation Readiness

Objective: Establish validated process windows for coating, sealing, and encapsulation steps.

Actions:

• Conducted parameter sensitivity analysis to rank CPPs (critical process parameters)
• Built process characterization matrices linking material and machine interactions
• Authored draft validation protocols for process qualification (PQ) and aseptic simulation runs

Impact:

• Defined CPPs and CQAs (critical quality attributes) necessary for validation
• Created foundation for Aseptic Process Qualification (APQ) and regulatory submission support

5. Aseptic Process Qualification (APQ) Support

Objective: Develop process simulation protocols to demonstrate aseptic integrity of device manufacturing.

Actions:

• Collaborated with QA, Validation, and Manufacturing Science to establish media-fill simulation plans
• Conducted airflow visualization studies
• Authored protocols, acceptance criteria, and risk-based sampling plans
• Supported documentation alignment with FDA and EMA expectations for combination products

Impact:

• Ensured manufacturing process readiness for clinical-scale aseptic runs
• Provided framework for subsequent PPQ execution

6. Cross-Functional Process Excellence Initiatives

Highlights:

• Co-led Kaizen events to optimize material flow and documentation cycle times
• Supported Supply Chain in defining critical vendor specifications and inspection plans
• Worked with R&D, Cell Manufacturing, and CMC to establish encapsulation processes
• Worked with Facilities and EHS to streamline cleanroom gowning and logistics
• Partnered with QA leadership to align documentation practices with cGMP and 21 CFR Part 820

Impact:

• Built strong cross-functional rapport and visibility across QA, R&D, Facilities, and Manufacturing Science
• Recognized internally for driving process ownership and operational discipline

Equipment Material Selection

Analysis Performed: Conducted comprehensive weight analysis and lead time comparison between Aluminum and Stainless Steel equipment options.

Validation: Performed AVS (Automated Vision System) and mockup validation before finalizing material choice.

Decision: Selected optimal material for performance, timeline, and GMP requirements despite longer lead time considerations.

Final Seal Enhancements

Implemented comprehensive improvements to the glue dispensing system to eliminate microbubbles and ensure consistent seal quality across all production units. Enhanced UV curing process and visibility protocols.

Design Updates & Iterations

Multiple design iterations focused on improving operator ergonomics, equipment reliability, and process robustness for GMP manufacturing environment. All changes validated through rigorous testing protocols.

Cell Injector Panel Resolution

Developed and implemented panel improvements to enhance repeatability and reduce operator-dependent variability in the cell injection process.

Scope: Led manufacturing engineering for novel drug-device combination product from pilot phase through commercial readiness (2019-2025)

Key Achievement: Single-handedly led second shift manufacturing engineering, managing production scale-up from 1 to 250 devices per month while improving yield from 1% to 20%

Impact: Authored >100 controlled documents (SOPs, WIs, protocols), closed >20 Quality Events with CAPA, and established standardized framework for device process characterization

1. Coating Process Development & Cycle Time Reduction (2023-2024)

Objective: Develop and scale up a proprietary semi-automated coating process for cell encapsulation devices while minimizing cycle time and improving consistency.

Challenge: Initial coating workflow (mixing, dispensing, curing, inspection) was highly manual, creating bottlenecks as production scaled from 1 to 250 devices per month. Process variability risked non-uniform coating thickness and adhesion failures.

Actions:

• Performed full process mapping and time-motion study to isolate non-value-added steps
• Conducted Design of Experiments (DOE) to correlate coating thickness with curing time, humidity, and temperature
• Introduced parallel tray processing and optimized oven dwell times
• Redesigned layout ergonomics using Lean principles (5S and Spaghetti analysis)
• Collaborated with Facilities to integrate HVAC control zoning for pre- and post-coat areas

Impact:

• 90.75% cycle-time reduction while maintaining coating uniformity and adhesion strength
• Improved process production by 140% and yield by 50% enabling readiness for GMP production
• Served as Subject Matter Expert (SME) for coating processes, authoring SOPs and work instructions

2. Leak Tester Equipment Redesign (2024)

Objective: Eliminate production bottlenecks and improve test reproducibility in post-seal device leak testing.

Challenge: Early-stage testing instruments showed significant signal drift resulting in ambiguous pass/fail outcomes. Fixtures lacked mechanical repeatability, introducing variation between test stations.

Actions:

• Built brand new equipment to eliminate redundancy due to singular nature of equipment
• Partnered with vendors to redesign leak tester logic using pressure-hold verification algorithm
• Developed custom fixture ensuring repeatable clamping and uniform pressure distribution
• Standardized calibration protocols and implemented routine gauge R&R testing

Impact:

• Reduced false failures by ~70%
• Test cycle time reduced by 40% through automation and auto-zeroing functions
• Instrument reliability validated under simulated aseptic runs

3. Coating Lab Redesign and Facility Optimization (2022)

Objective: Reconfigure existing lab to accommodate higher throughput and GMP-compliant coating operations. Scale up from Coating Pilot lab to CMC production.

Challenge: Assessed cross-traffic between coated and uncoated devices and personnel, leading to contamination risks and inefficiencies.

Actions:

• Led cross-functional collaboration between Facilities, EH&S, and R&D for layout design
• Created new lab layout for CMC with 2 fume hoods and coating stations
• Implemented segregation of clean vs. non-clean operations and improved material flow pathways
• Designed new bench layouts with improved utility access and ergonomic workflows
• Authored facility readiness plan including HVAC balancing, power load documentation, and visual management boards

Impact:

• Reduced operator walking distance by 40% using spaghetti diagrams
• Established clear GMP flow for materials and waste
• Improved lab audit readiness and operational safety

4. Assembly-Visual Inspection Yield Improvement (2022-2023)

Objective: Improve assembly process and visual inspection yield to reduce scrap and rework.

Actions:

• Conducted root cause analysis of assembly defects and inspection failures
• Implemented process improvements for assembly techniques
• Enhanced visual inspection criteria and operator training
• Optimized lighting and magnification for inspection stations

Impact:

• Improved assembly yield by approximately 45%
• Reduced scrap rates and rework requirements
• Established standardized inspection protocols

5. Leak Test Repair Process Optimization (2023)

Objective: Optimize leak test repair process to improve device recovery and reduce waste.

Actions:

• Analyzed leak test failure modes and repair success rates
• Developed improved repair procedures and techniques
• Implemented quality checks for repair verification
• Trained operators on new repair protocols

Impact:

• Improved repair reliability by 62%
• Reduced device waste and improved material utilization
• Established standardized repair procedures

6. Gluing Robot Replacement and Process Enhancement (2024)

Objective: Replace aging gluing robot system and optimize adhesive dispensing process.

Actions:

• Evaluated and selected new robotic dispensing system
• Optimized dispense parameters and path programming
• Implemented vision-guided positioning for improved accuracy
• Validated new system under production conditions

Impact:

• Achieved 71.65% yield improvement in gluing process
• Reduced adhesive defects by 59%
• Improved process repeatability and consistency

7. Ethanol Soak Cycle Time Reduction (2022)

Objective: Reduce ethanol soak cycle time while maintaining sterilization efficacy.

Actions:

• Conducted validation studies on reduced soak times
• Optimized ethanol concentration and temperature parameters
• Implemented automated timing controls
• Verified sterilization efficacy through microbial studies

Impact:

• Reduced cycle time by 90%
• Maintained sterilization effectiveness
• Improved throughput and reduced bottlenecks

Comprehensive Documentation Program

Authored and revised:

• >100 controlled documents including Standard Operating Procedures (SOPs), batch records, and training documents
• >20 Quality Events with CAPA investigations and root cause analysis
• Risk assessment templates, deviation categorization charts, and root cause checklists for engineering teams
• Mentored junior engineers on process characterization and GMP documentation practices

Impact:

• Standardized engineering documentation across the device manufacturing group
• Improved audit readiness and process knowledge retention
• Established framework for device process characterization

Key Collaborations:

• Co-led Kaizen events to optimize material flow and documentation cycle times
• Supported Supply Chain in defining critical vendor specifications and inspection plans
• Worked with Facilities and EHS to streamline cleanroom gowning and logistics
• Partnered with QA leadership to align documentation practices with cGMP and 21 CFR Part 820

Impact:

• Built strong cross-functional rapport and visibility across QA, R&D, Facilities, and Manufacturing Science
• Recognized internally for driving process ownership and operational discipline