Milap Shah
Bloomington,IN
Summary
Manufacturing and Quality Engineer with experience in pharmaceutical and medical device environments, specializing in sterile fill-finish operations, equipment troubleshooting, and process optimization. Lean Six Sigma Black Belt certified, with a strong track record of driving data-driven improvements and enhancing process reliability. Proven ability to support manufacturing line startup, collaborate with OEM vendors and validation teams, and contribute to equipment commissioning and qualification (IQ/OQ/PQ). Experienced in cGMP environments with expertise in CAPA, root cause analysis, and continuous improvement.
Overview
9
9
years of professional experience
Work History
Senior Analyst, Quality Assurance
Novo Nordisk
Bloomington, IN
12.2024 - Current
- Act as a cross-functional liaison between manufacturing, engineering, and quality to support fill-finish operations and equipment performance
- Lead investigations on automated manufacturing systems, isolators, and aseptic processing equipment
- Identify equipment-related failure modes and drive CAPAs focused on long-term reliability and process robustness
- Partner with engineering and validation teams to support equipment commissioning and qualification (IQ/OQ/PQ) activities
- Analyze process trends, alarms, batch, and laboratory data (via LIMS systems such as LabVantage) to improve system performance and reduce deviations
- Support process optimization initiatives, improving operational efficiency and reducing variability
- Develop and update SOPs, work instructions, and training materials aligned with evolving equipment and processes
- Mentor junior team members and support knowledge transfer across operations and quality teams
- Ensure compliance with cGMP and FDA regulations while driving continuous improvement initiatives
Senior Analyst, QA
Catalent Biologics
Bloomington, IN
04.2023 - 12.2024
- Authored and led deviation investigations within required timelines in a GMP-regulated manufacturing environment
- Collaborated with cross-functional teams (manufacturing, engineering, QA) to identify root causes and define CAPAs
- Conducted root cause analysis (5 Whys, Fishbone) for process and equipment-related deviations
- Gathered and analyzed process, equipment, and laboratory data, including review of records within LIMS systems (LabVantage)
Evaluated deviations for product and process impact, including SISPQ considerations - Developed and executed CAPA plans, ensuring effectiveness through monitoring and follow-up
- Ensured investigations complied with cGMP, FDA regulations, and internal quality systems
- Contributed to continuous improvement by identifying recurring issues and supporting process enhancements
- Prepared detailed investigation reports including root cause, impact assessment, and CAPA recommendations
Process Engineer IV
Jabil Inc.
Clinton, MA
05.2022 - 04.2023
- Led process development and optimization for manufacturing systems, including equipment installation, commissioning, and qualification (IQ/OQ/PQ)
- Authored and executed validation documentation (URS, IQ/OQ/PQ protocols) supporting equipment and system qualification
- Acted as primary interface between OEM vendors and cross-functional teams during equipment implementation and startup
Supported equipment integration and system connectivity within manufacturing environments - Owned process performance and equipment reliability, driving troubleshooting and continuous improvement initiatives
Executed and supported change control activities, including technical writing, impact assessments, and implementation tracking within QMS systems - Partnered with validation, IT, and site SMEs to ensure alignment on system changes and compliance requirements
Performed risk assessments (PFMEA/DFMEA) to evaluate impact of equipment and process changes - Applied Lean Six Sigma methodologies (DOE, SPC, regression, ANOVA) to improve process capability and reduce variability
- Developed SOPs, control plans, and work instructions to support scalable and compliant manufacturing operations
- Analyzed manufacturing data to drive data-driven decision making and performance improvements
Quality Engineer II
Sanofi Genzyme
Boston, MA
08.2021 - 05.2022
- Supported manufacturing operations and process compliance within cGMP-regulated environments
- Led and supported deviation investigations involving equipment and process failures
- Implemented CAPAs to improve process reliability and reduce recurrence of manufacturing issues.
- Participated in change control activities impacting manufacturing systems and equipment.
- Support instrument qualification and validation activities, including review and contribution to IQ/OQ documentation and related deliverables.
- Collaborate with cross-functional teams to ensure instrument readiness and compliance for system integration (e.g., LIMS/LabVantage-type systems).
- Maintain and review GMP documentation and validation records to support instrument lifecycle management.
- Author and execute change controls, including drafting technical justifications and assembling supporting documentation for QA approval
- Perform risk assessments (FMEA/PFMEA) for process and equipment changes
- Support validation documentation, batch record review, and process verification activities
- Drive continuous improvement initiatives using Lean Six Sigma methodologies
Quality Engineer
WrapTite Industries
Cleveland, Oh
06.2020 - 07.2021
- Supported manufacturing process improvement initiatives to enhance product quality and efficiency
- Developed and implemented process controls, SOPs, and quality procedures
- Led CAPA and root cause investigations related to manufacturing defects
- Utilized Lean Six Sigma tools to reduce defects and improve production performance
- Collaborated with operations to optimize manufacturing workflows and reduce variability
- Supported audits and ensured compliance with FDA and ISO standards
Quality Engineer
Konark Industries
Gujarat, India
06.2017 - 07.2019
- Developed and implemented process control strategies for manufacturing operations
- Utilized SPC and data analysis to monitor and improve process performance
- Conducted supplier quality evaluations and audits
- Supported process optimization and continuous improvement initiatives
- Ensured compliance with quality standards and manufacturing best practices
Education
Master of Science - Industrial Engineering
SUNY At Binghamton
Binghamton, NY08.2021
Lean Six Sigma Black Belt Certification -
Management And Strategy Institute
Downingtown, PA08.2021
Bachelor of Science - Mechanical Engineering
Gujarat Technological University
Ahmedabad, GJ2018
Skills
- Process Development & Scale-Up
- Process & Equipment Qualification & Validation (IQ/OQ/PQ)
- Statistical Process Control (SPC)
- Design of Experiments (DOE)
- Data Analysis & Process Trending
- Root Cause Analysis (5 Why, Fishbone, 8D)
- Failure Mode & Effects Analysis (FMEA / PFMEA)
- CAPA Management
- Deviation Investigations
- Change Control
- LabVantage/LIMS
- CGMP (21 CFR Part 210/211/820)
- Good Documentation Practices (GDP)
- Audit Support & Regulatory Inspections
Timeline
Senior Analyst, Quality Assurance
Novo Nordisk
12.2024 - Current
Senior Analyst, QA
Catalent Biologics
04.2023 - 12.2024
Process Engineer IV
Jabil Inc.
05.2022 - 04.2023
Quality Engineer II
Sanofi Genzyme
08.2021 - 05.2022
Quality Engineer
WrapTite Industries
06.2020 - 07.2021
Quality Engineer
Konark Industries
06.2017 - 07.2019
Master of Science - Industrial Engineering
SUNY At Binghamton
Lean Six Sigma Black Belt Certification -
Management And Strategy Institute
Bachelor of Science - Mechanical Engineering
Gujarat Technological University