Validation Engineer 3

Merck•Bedford, MA

10d•Onsite

About The Position

MilliporeSigma in Bedford, MA is seeking a Product Validation Engineer 3. As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate in filtration product development teams to understand the new product and its applications.

Requirements

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 7+ years of experience in process or product development/validation -OR- Master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 5+ years of experience in process or product development/validation
5+ years of experience with FMEA/risk analysis, product failure and root cause analysis
5+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practices (GDP)

Nice To Haves

Experience in Medical Device or Life Science industries
Experience with filtration and chromatography products
Experience in the development and execution of test method validations
Experience using statistical tools such as Minitab for capability analysis, Gage R&R’s, & DOE’s
Experience with product development and change control processes and working in cross functional teams
Experience leading/supervising a small team
Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry
Proficiency in equipment calibration, troubleshooting and repairs
ASQ – CQE Certification

Responsibilities

Implement an efficient and thorough validation test matrix, including development and validation of new test equipment and test methods
Author the validation test protocol, test execution oversight, data analysis, and authoring the validation report
Participate in process and product development supporting DOE studies and data analyses and the creation of product design specifications and risk assessments
Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, shelf-life studies, and customer application inquiries
Interact effectively with other groups, such as R&D development teams, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance