Product Validation Engineer 3 - R&D

Merck•Bedford, MA

1d•Onsite

About The Position

MilliporeSigma is seeking a Product Validation Engineer 3 to join the R&D Validation & Applications Center (VAC) Engineering team in Bedford, Massachusetts. The role participates in filtration product development teams, building an understanding of new products and their applications. It develops and carries out product and process validation activities, supports product development and change processes, and collaborates with teams across the organization. Occasional travel to manufacturing facilities may be required, at less than 10%. The position does not offer work authorization sponsorship; external applicants must be eligible to work in the United States.

Requirements

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science, or another engineering or scientific field, plus at least 7 years of process or product development/validation experience; or a relevant master’s degree plus at least 5 years of process or product development/validation experience and at least 5 years of FMEA/risk analysis, product failure, and root cause analysis experience.
At least 5 years of experience with process and product/equipment validations (IQ/OQ/PQ), including authoring formal protocols and reports using Good Documentation Practices (GDP).

Nice To Haves

Experience in the medical device or life science industries.
Experience with filtration and chromatography products.
Experience developing and executing test method validations.
Experience using statistical tools such as Minitab for capability analysis, Gage R&R, and DOE.
Experience with product development and change control processes and working in cross-functional teams.
Experience leading or supervising a small team.
Knowledge of applicable FDA regulations, USP requirements, and regulatory requirements for products used in the biopharmaceutical or medical device industry.
Proficiency in equipment calibration, troubleshooting, and repairs.
ASQ Certified Quality Engineer (CQE) certification.

Responsibilities

Implement an efficient and thorough validation test matrix, including developing and validating test equipment and methods.
Author validation test protocols and reports, oversee test execution, and analyze data.
Support process and product development, including design of experiments (DOE) studies, data analysis, product design specifications, and risk assessments.
Collaborate with Operations, Product Management, and Field Marketing on product or process change requests, raw material qualifications, shelf-life studies, and customer application inquiries.
Work effectively with R&D development teams, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance.