Overview
Work History
Education
Skills
Certification
Timeline
Generic

HAVISHYA PILLALAMARRI

Nashua

Overview

8
8
years of professional experience
1
1
Certification

Work History

Sr. Packaging Engineer

Getinge (Formerly Atrium Medical Corporation)
Merrimack
05.2022 - Current
  • Assisted in troubleshooting activities on the shop floor whenever required.
  • Ensured compliance with company safety protocols and industry regulations while designing and testing packages.
  • Developed manufacturing procedures and monitored designs to improve operations and product quality.
  • Identified opportunities for improvement in production throughputs due to better package designs, materials, processes.
  • Analyzed product design to determine appropriate packaging materials and methods.

Packaging/Validation Engineer

Anika Therapeutics, Inc.
01.2017 - Current
  • Worked as the packaging engineering lead of a team created to address the recall of a product due to customer reports and complaints of product quality concerns
  • Performed full qualification and validation of new packaging material to launch the product back on the market within a year of the recall
  • Responsible for material, labor and time savings by implementing fully automated vision system on horizontal cartoner by eliminating 100% manual visual inspection
  • Responsible for ensuring and maintaining supply chain continuity, and no operations down-time by sourcing, qualifying, implementing, and validating packaging material from a minority women-owned small business material supplier during a global pandemic
  • Quickly got acquainted with newly implemented EU-MDR rules and regulations and helped fast-track the submission of technical documentation for products that were due for recertification to be sold in in European Union and helped address and close gaps found during review by being prompt and thinking on-my feet
  • Served as the packaging engineering lead for NPD/launch/510(k) submission of novel osteo-arthritic device by helping develop packaging specs for the CMO based in Ireland, worked on developing and justifying packaging specs and performing packaging stability, transportation studies and in-process specs, as needed
  • Wrote Validation Project Plan for Packaging Line Upgrades, installed automatic label applicators, fully automated Vision Inspection system on horizontal cartoning and carton printing machines, Multifeeder IFU feeder, horizontal case packer and case label printing machine
  • Act as a technical lead in multi-disciplined project teams and projects of diverse scope
  • Prepared draft-operating procedures for new equipment and processes and worked with Document Control, Quality Assurance, Operations and Regulatory Affairs to ensure final processes were implemented through the document mastering process
  • Evaluated the proposed changes with regard to the sufficiency of design, biocompatibility, verification and validation, sterilization and packaging validation, process validation, inspection procedures
  • Updated packaging validation reports, batch records, work instructions, SOPs, operator trainings based on gap analysis performed for MDR submission
  • Reviewed and developed validation deliverables - master plan/summary Report, URS, FRS, Requirement traceability matrix (RTM), IQ, OQ and PQ protocols
  • Worked with external test labs in order to coordinate the testing of packaging films for biocapacity, particulate matters, ink compatibility, packaging integrity of sterile barrier pkg systems, packaging and product stability chambers for shelf-life extension

Education

Master of Science - Chemical Engineering, Plastics Materials

University of Massachusetts
Lowell
01.2017

Bachelor of Technology - Chemical Engineering

Jawaharlal Nehru Technological University
Hyderabad
01.2015

Skills

  • ISO 11607-1 & 2
  • ASTM D4169, ASTM D7386 and environmental conditioning
  • Agile PLM
  • DHF DocuBOM maintenance and updates
  • Purchased Part Specification
  • Package testing methods
  • Barrier properties knowledge
  • Transportation simulation
  • Continuous improvement mindset

Certification

  • ISTA PDP (Packaging Dynamics Professional) Certified
  • IoPP CPIT (Certified Packaging Professional- In Training)
  • Oriel STAT A MATRIX- ISO 14971 Medical Device Risk Management and Analysis
  • Merrimack Data-Driven Investigator Certification Program (MEDIC)

Timeline

Sr. Packaging Engineer

Getinge (Formerly Atrium Medical Corporation)
05.2022 - Current

Packaging/Validation Engineer

Anika Therapeutics, Inc.
01.2017 - Current
  • ISTA PDP (Packaging Dynamics Professional) Certified
  • IoPP CPIT (Certified Packaging Professional- In Training)
  • Oriel STAT A MATRIX- ISO 14971 Medical Device Risk Management and Analysis
  • Merrimack Data-Driven Investigator Certification Program (MEDIC)

Master of Science - Chemical Engineering, Plastics Materials

University of Massachusetts

Bachelor of Technology - Chemical Engineering

Jawaharlal Nehru Technological University

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HAVISHYA PILLALAMARRI