Takeda · 5 hours ago
Packaging Development Engineer
Lexington, MA
Full-time
Hybrid
Mid, Senior Level
$135K/yr - $206K/yr
3+ years expTakeda Development Center Americas, Inc. is seeking a Packaging Development Engineer. The role involves providing technical expertise in packaging development, regulatory submissions, and project execution related to pharmaceutical and medical device packaging.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs
Author and review of regulatory information packages and filings/submissions (IND/NDA/BLA)
Execute or lead all aspects of a packaging project delivering early phase evaluation to the device sub-team
Deliver on specific performance indicators, including but not limited to (a) successful concept design solutions, (b) visualization of concepts and prototyping as appropriate, (c) successful human factors studies, (d) supporting regulatory submission, and (e) realistic and manufacturable design concepts
Execution Lead for one or more processes, including but not limited to (i) New Product Packaging Technology, (ii) Combination Product and Device Packaging, (iii) Packaging & Art-Work Specifications process including device instructions for use, (v) Packaging Process Development
Execute technical transfer of packaging material and process specifications from development to commercial GMP manufacturing site
Ensures proper level of documentation and covers packaging related aspects in compliance with regulations and cGMP
Technical interface between commercial marketing and R&D for packaging design
Evaluate and resolve technical challenges related to product stability and manufacturing under GMP expectations and requirements
Up to 25% domestic and international travel required for vendor site visits, manufacturing site visits, and technical audits
Up to 40% remote work allowed
Qualification
Required
Master's degree in Packaging Science, Packaging Engineering, or related field, plus 3 years of related experience, OR Bachelor's degree in Packaging Science, Packaging Engineering, or related field, plus 5 years of related experience
Prior experience must include: design, develop and qualify sterile pharmaceutical, medical device and combination product packaging with demonstrated success and commercialization
Demonstrate pharmaceutical packaging development knowledge for drug product manufacturing processes and/or packaging solutions for biologics in primary containers and devices
Utilize cGMP requirements (ISO 13485, 21 CFR 820, 21 CFR 210, 21 CFR 211) and demonstrate application of industry guidance/standards documents (e.g., ISPE, PDA, ASTM, ISO, ICH, Pharmacopeias) for combination product submissions
Develop and validate packaging testing methods and procedures following ISO 11607 for use in design verification testing
Develop and validate packaging testing methods and procedures following compendia testing for CCIT (USP 1207, USP 381/382)
Benefits
U.S. based employees may be eligible for short-term and/or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
CorD Magazine
2026-02-03
EIN Presswire
2026-02-02
Company data provided by crunchbase