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Packaging Engineer Medical Device

Location:
New Milford, NJ
Salary:
90,000
Posted:
December 28, 2023

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Resume:

Sachii Vohra

ad2afw@r.postjobfree.com

732-***-****

SUMMARY:

6+ years of experience as a Packaging Engineer in a Medical Device Environment.

I take care of all the company product Trials in the plant.

Working experience of CAPE software for pallet palletization.

Extensive plant experience with Robotic arms.

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 for new-generation capital equipment and consumables using SolidWorks.

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.

Work Experience:

PIM Brands- One PIM Plaza Jan 9th 2023-Present

Park Ridge, NJ 07656 USA

Packaging Engineer

Description

PIM is one of Americas leading makers of popular brand-name snacks and confections, including Welchs Fruit Snacks, Original Gummi FunMix, 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.

The Packaging Engineer will provide general technical support for initial production runs and troubleshooting of packaging lines at internal and external production locations.

To maintain and evolve a sustainable packaging program to be in alignment with internal and industry targets.

Assist team to create an innovation portfolio of new and emerging sustainable packaging options for product innovations, promotional displays, graphic refreshes and customer specific packs across all product types and brands

BD Pharmaceutical, Franklin Lakes NJ April 2022-October 22nd

R&D Packaging Engineer/ Labelling Specialist

Developed protocols and reports for Packaging Characterization studies and Design Verification testing.

Review and manage regulatory and compliance.

Manage protruding activities of labelling and artwork

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.

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 engineer supporting 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.

Education: Bachelor’s in Science, Ravishankar University, Raipur.



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