Packaging Development Engineer

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Job Description

Pursuant to Section 20 C.F.R. 656.10 you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas Inc. for the following job opportunity:

JOB LOCATION: Lexington MA

POSITION: Packaging Development Engineer

POSITION DESCRIPTION: Takeda Development Center Americas Inc. is seeking a Packaging Development Engineer with the following duties: 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.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

REQUIREMENTS: Masters degree in Packaging Science Packaging Engineering or related field plus 3 years of related experience OR Bachelors 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 (ISOCFR 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).

Full time. $135000 - $206100 per year.

Qualified applicants can apply at . Please reference job #R0173844. EOE

Any individual may provide documentary evidence bearing on this application with information on available workers and information on wages and working conditions to the Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW Room N-5311 Washington DC 20210.

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