Process Engineering specializing in CPV and statically analysis

Sarjil Mansuri

SUMMARY

Driven Chemical Engineer with 5 years in MS&T and Manufacturing in Cell Therapy Lentiviral Vector and Drug Product, and Medical Devices.

PROFESSIONAL EXPERIENCE

Bristol Myers Squibb Summit, New Jersey

Process Engineer – Viral Vector Global MSAT November 2022 – Current

Created, developed, and lead monthly process data review meetings for in-process control, critical process parameters, key process parameters with internal and external partners to monitor manufacturing process health.

Authored, reviewed, and tabulated monthly data utilizing Excel and JMP 17 to develop control process verification (CPV) report which led to process improvements and addressing IR responses from Government Agencies.

Created CAPAs and change control for manufacturing process and electronic Batch records to help reduce Man/Personnel caused deviation and increase the ability to capture all pertinent information in relation to the process control strategy.

Authored and reviewed data packages and regulatory filings to support Life Cycle Management projects (Replacement of Clarification Filter, Growth Media Expiry Extension, High Dose GI FBS, etc).

Conducted root cause analyses for Lentiviral Vector manufacturing and process investigations and provided impact assessments to internal team and external CMOs efficiently to ensure prompt release of lentiviral vector batches. Johnson & Johnson Raritan, New Jersey

Associate Technology Specialist – Cell Therapy Drug Product November 2020 – October 2022

Conducted root cause analyses for CAR-T manufacturing and process investigations utilizing the 5 Whys, Fishbone Diagram, PFMEA, 8D and presenting data with Pareto Chart, Scatter Plot, etc.

Successfully investigated and authored 75+ investigations including OOS for process and product related issues for Manufacturing, Warehouse, Supply Chain, QA/QC, and Facilities.

Presented technical investigation to Johnson & Johnson compliance Leadership and U.S FDA for commercial filing.

Initiated several CAPAs and change controls to automate warehouse entries, inventory controls, and manufacturing processes to reduce Man/Personnel caused deviations.

Established new parameters for electronical and paper batch records during processing to allow for operator flexibility while maintaining acceptable release specifications.

Served as project manager to coordinate between multiple departments to ensure all patient batches are released while compliance and quality standards were satisfied.

Provided impact assessments efficiently to ensure prompt release of patient batches.

Presented investigation findings to educate and re-instruct over 50+ warehouse and operations employees to reduce recurring issues.

Coordinated and communicated between multiple Johnson and Johnson sites to eliminate recurring issues identified during shipment of patient apheresis material.

Humanscale Piscataway, New Jersey

Quality Engineer March 2018 – November 2020

Conducted risk assessments and assigned Risk Assessment Scores on nonconforming material and processes.

Lead internal audit on production line and internal processes to ensure product compliance and regulatory compliance.

Closed 50+ CAPAs and led all phases of CAPA from investigation to monitoring to ensure change effectiveness.

Authored training materials, production validation test plans, SOP's, and QC Criteria related to the Healthcare product lines.

Supported cross functional team activities from supervising operator training, auditing BOM Audits, supporting Field Service, and assisting sales with technical and regulatory information.

Developed sampling procedures according to AQL Standards and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.

Investigated customer returns based of on failure modes and dropped customer returns by 5%. Analyzed and organized the failure modes with Pareto chart to prioritize complaints to research group to close Corrective Action. EDUCATION

Stevens Institute of Technology, Hoboken, NJ

Bachelor of Engineering in Chemical Engineering

GPA: 3.05 Honors: Dean’s List Graduated: May 2015

SKILLS

Engineering: Stripping, Batch and Semi-Batch Operations, Process Development, Continuous Process Verification (CPV), Clinical/Commercial Manufacturing, Contract Manufacturing Organization (CMO) Management, CAPAs, Risk Assessments, RCA, Change Control Management

Software: Microsoft Office’ 10: PowerPoint, Excel, Visio, Access; SharePoint, SAP, INFOR, JMP 17 US Citizen

Contact this candidate