Validation Engineer 2 - Product R&D

MilliporeSigma; Bedford (MA); On-site; USD 84,900 - 127,300; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in Bedford, MA is seeking a Product Validation Engineer 2 to join the R&D Validation & Applications Center. You will develop and implement an efficient validation strategy to ensure robust product performance aligned with design and intended applications.

You will author protocols, support DOE studies, and collaborate across functions to drive product development, risk assessment, and test method validations. Occasional travel (<10%) may be required.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or related 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 related 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 IQ/OQ/PQ validations and GDP documentation

Responsibilities

• Author validation test protocols; manage lab test requests, test execution, data analysis, and reporting
• Support DOE studies, data analyses, and creation of product design specs and risk assessments
• Collaborate with Operations, Product Management, and Field Marketing on product/process changes and material qualifications
• Develop and validate new test methods, equipment, and measurement systems for product validation
• Coordinate with R&D, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance groups

Skills

FMEA

GDP

Process validation

Product validation

DOE analysis

Cross-functional

Gage R&R

Minitab

FDA/USP regs

Education

Bachelor’s degree in Chemical/Biomedical/Mechanical Eng or related

Master’s degree in Chemical/Biomedical/Mechanical Eng or related

Tools

Minitab

DOE software

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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%).

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.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!