Product Validation Engineer 3 - R&D

The businesses of Merck KGaA, Darmstadt, Germany•Bedford, MA

1d•$80,400 - $140,300•Onsite

About The Position

MilliporeSigma is seeking a Product Validation Engineer 3 in Bedford, Massachusetts, to join the R&D Validation & Applications Center (VAC) Engineering team. The role participates in filtration product development teams to understand new products and their applications. It involves developing and executing validation approaches, supporting product and process development, and collaborating with cross-functional teams. Occasional travel to manufacturing facilities may be required, at less than 10%. The role 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 experience in process or product development/validation; OR a master’s degree in one of these fields, plus at least 5 years of experience in process or product development/validation.
At least 5 years of experience with FMEA/risk analysis, product failure and root cause analysis.
At least 5 years of experience with process and product/equipment validations (IQ/OQ/PQ), 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 – CQE certification.

Responsibilities

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