Packaging Engineer Medical Device
Resume:
Sachii Vohra
******.*******@*****.***
SUMMARY:
●6+ years of experience as a Packaging Engineer in a Medical Device Environment.
●Worked on designing and developing packaging and labeling for capital equipment, consumables, components, spare parts, accessories, and Field Replaceable Units (FRUs).
●Worked on Packaging Design improvement based on Corrective and Preventive Action (CAPA) and Non-Conformances (NCs).
●Developed protocols and reports for Packaging Characterization studies and Design Verification testing.
●Involved in activities related to the project using GAMP5, ISO, FDA QSR, 21 CFR Part 11.
●Extensive Device specific engineering and development, and manufacturing for Classes II & III, ISO 9001, ISO
●Involved in packaging process development activities, including new work instructions, procedures and templates.
●Working on labeling artwork, development, and verification for new generation products.
●Involved in unit-level testing for Labels.
●TAYAK Tool for sustainability Analysis.
Work Experience:
PIM Brands- One PIM Plaza Jan 9, 2023-Present
Packaging Engineer
PIM is one of America's leading makers of popular brand-name snacks and confections, including Welch Fruit Snacks, Original Gummi Fun Mix, Sun-Maid Chocolate Raisins, Sour Jacks Sour Candies, and more. We are passionate about delivering delicious and innovative snacks and treats developed with the highest quality ingredients and standards, offered whenever and wherever consumers want them. More simply put, we make the brands you love!
JOB SUMMARY
●To design, develop, and commercialize new packaging for high-speed manufacturing of confections and fruit snack products.
●To maintain and evolve a sustainable packaging program to be in alignment with internal and industry targets.
●Assist team in creating an innovative portfolio of new and emerging sustainable packaging options for product innovations, promotional displays, and customer-specific packs across all product types and brands.
●Provided optimized shipping solutions in Cape and secured pallets for stability during transit.
●Engaged customers to gather detailed requirements and preferences for packaging design.
●Conducted market research to identify innovative solutions and align with industry trends.
●Developed initial design concepts, factoring in materials, production methods, and costs.
●Effectively managed packaging complaints, resolved claims, and implemented corrective and preventive actions.
●Tested new materials, evaluated their performance, and implemented automated solutions to streamline production processes.
●Designed and coordinated multi-floor display solutions according to customer requirements.
●Established clear communication channels and assessed production capabilities across multiple plants.
●Collaborated with cross-functional teams to address packaging challenges and implement sustainable practices.
●Designed and executed multi-floor displays tailored to customer requirements, enhancing product visibility and market appeal.
●Established cross-functional collaboration to align packaging strategies with manufacturing, logistics, and marketing goals.
●Conducted ship trials and ensured all e-commerce products were Amazon certified, meeting strict packaging and durability standards.
BD Pharmaceutical, Franklin Lakes NJ April 2022-Oct 22
R&D Packaging Engineer/ Medical Device
●Developed protocols and reports for Packaging Characterization studies and Design Verification testing.
●Working on labeling artwork, development, and verification for new generation products.
●Working on the new test procedure for the Sutherland rub test for containment products.
●Working on the MSA, Visual Inspection Protocol, and Test report.
●Worked on the plant Ink change protocol and T0 test report.
●Good understanding of 21CFR11 for design, Adobe pro for Redlines & Minitab Software.
●Working on labeling artwork, development, and verification for new generation products.
●Electronic Document Management System (EDMS), and Inventory management system (IMS).
●Experience in Active and passive thermal protection system (TPS) qualifications
● worked in temperature-controlled distribution solutions.
Bausch & Lomb Surgical, St. Louis, MO Oct 2020-Jan 2022
R&D Packaging Engineer/ Medical Device
●Evaluate, Analyze and Remediate (obsolete or update) Transit Testing for multiple products in the suture, mesh, biosurgery, Endo devices, and other medical device products used for various medical procedures.
●Review and support risk management to ensure a high level of compliance to FDA QSR 21 CFR 820, ISO 13485, and ISO 14971and European standards in all assigned areas.
●Generate and perform Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) validation protocols for sealing rooms and manufacturing equipment according to ISO 11607.
●Reviewed and modified existing Standard Operating Systems (SOPs) for a Document management system, System Administration, Change Control Procedures, and Testing SOPs.
●Participating in developing EU MDR Documentation for Notified Bodies.
Structure Medical, Mooresville, NC Jul 2019-Sep 2020
Packaging Engineer/ Med Device
●Packaging engineers support various aspects of package development activities for product launches including prototype development, transit testing, stability testing, sterility testing.
●Managed implementation and support of end-to-end roll-out of serialization line upgrades on four packaging lines to meet FDA regulatory compliance requirements.
●Recognized for three patent submissions that are recently moving into design and development work.
●Prepared Quality Review Reports and validated existing SOP's and Batch Reports.
●Drafted packaging test reports to comply with ISO 11607 and other various qualifications and validations.
●Evaluated complaints to determine whether an adverse event report/Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting.
Lake Region Medical, Trenton, GA Apr 2017-Jun 2019
Packaging Engineer
●Created and improved current packaging material and design specifications.
●Plan and execute activities regarding the design and development of sterile barrier packaging for medical devices.
●Develop and execute process validation risk management plans including FEMA and DMCA.
●Used Quick Test Professional (QTP) to automate the Regression Test cases and executed them for different releases.
●Ensured that the documentation adhering to the FDA Regulatory Requirements.
●Maintain the highest production/documentation standards by Federal and State regulations with FDA-approved
Education: Bachelors in Electronics & Telecommunication. Ravishankar University, Raipur.
Master in Packaging Engineering-Rutgers University-New Brunswick, NJ
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