Full Job Description
Your Role:
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.
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
This position may include occasional travel to our manufacturing facilities
Who You Are
Minimum Qualifications:
• 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 plus
• 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)
Preferred Qualifications:
• 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
Pay Range for this position: $80,400 - $140,300
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
