Packaging Development Engineer

Takeda Development Center Americas, Inc.

Lexington, MA, US
Base: $135,000 - $206,100 py; bonus/equity: not sp...
Fully remote
Packaging material selection and qualification
Regulatory information packages and filings
Human factors studies
Takeda Development Center Americas, Inc. is seeking a Packaging Development Engineer to provide technical expertise in packaging for pharmaceutical and medical devices. The role involves leading projects, ensuring regulatory compliance, and executing packaging design and testing

Job Summary

  • Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
  • Execute technical transfer of packaging material and process specifications from development to commercial GMP manufacturing site, ensuring compliance with regulations and cGMP.
  • U.S. based employees may be eligible for medical, dental, vision insurance, a 401(k) plan and company match, and other benefits.

Matching Summary

Match Score: 85

Takeda Development Center Americas, Inc. is seeking a Packaging Development Engineer to provide technical expertise in packaging for pharmaceutical and medical devices. The role involves leading projects, ensuring regulatory compliance, and executing packaging design and testing.

Salary

Base: $135,000 - $206,100 per year; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), PTO, etc.

Skills & Requirements

Must-have

  • packaging material selection and qualification
  • regulatory information packages and filings
  • human factors studies
  • combination product and device packaging
  • cGMP manufacturing site technical transfer
  • technical interface between marketing and R&D

Nice-to-have

  • vendor site visits
  • technical audits
  • remote work flexibility

Key Requirements

  • Master’s degree + 3 years experience OR Bachelor’s degree + 5 years experience
  • Design, develop, and qualify sterile pharmaceutical, medical device, and combination product packaging
  • Pharmaceutical packaging development knowledge for drug product manufacturing
  • Utilize cGMP requirements (ISO 13485, 21 CFR 820, 21 CFR 210, 21 CFR 211)
  • Develop and validate packaging testing methods following ISO 11607
  • Develop and validate packaging testing methods for CCIT (USP 1207, USP 381/382)

Work Rights

Not specified

Tailored Resume

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