Validation Engineer 2

JobsCloseBy Editorial Insights

MilliporeSigma in Bedford, MA is hiring a Product Validation Engineer 2 to join the R&D Validation and Applications Center. The role blends hands-on test method development with IQ/OQ/PQ validation, data analysis, and reporting to ensure filtration product performance. You will author protocols and reports, run lab tests, and support DOE studies while collaborating with Operations, Product Management, and other teams. Required: 2+ years in validation with FMEA, GDP-compliant documentation, and cross-functional teamwork; preferred: medical devices or life sciences background in filtration or chromatography. Onsite, US work authorization required; this role does not offer sponsorship, travel under 10%, salary 84,900–127,300 with benefits. Apply by highlighting validated methods, risk assessments, regulatory knowledge, and DOE or capability studies in Minitab, plus demonstrated impact on product quality.

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

MilliporeSigma in Bedford, MA is hiring a Product Validation Engineer 2.  As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate on filtration product development teams to understand the new product and its applications. Your contribution includes development and implementation of an efficient and thorough validation test strategy which ensures robust product performance specifications based on product design and intended applications.

Responsibilities:

• Authoring the validation test protocol, managing lab test requests, test execution, data analysis and authoring the report
• Participate in process and product development supporting DOE studies and data analyses and creation of the product design specifications and risk assessments
• Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications
• Hands-on design and development of new test methods, test equipment, and measurement systems which are utilized to characterize and validate new products, including troubleshooting, repairs, and identifying and implementing equipment upgrades/new technology and planning, documenting, and executing test method validations
• Effectively interact 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 <10%

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 4+ 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 3+ years of experience in process or product development/validation

-AND-

• 2+ years of experience with FMEA/risk analysis, product failure and root cause analysis 
• 3+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

Preferred Qualifications:

• Experience in Medical Device or Life Science industries
• Experience with filtration and chromatography products

• Experience with Product Development Process (PDP) and working on cross functional teams
• Experience in statistical analysis tools such as Capability, Gage R&R, DOE using Minitab
• Capable in the development and execution of test method validations
• Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry
• Experience in equipment troubleshooting and repairs

Pay Range for this position: $84,900 - $127,300 

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.

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