Validation Engineer 3 - Product R&D

Millipore Corporation; Bedford (MA); On-site; USD 80,000 - 140,000; 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 3 to design and execute rigorous validation programs for new test equipment and methods.

You will author protocols and reports, perform data analyses, and work with Operations, Product Management, and Quality to support product development, risk assessments, and design changes. Some travel (<10%) may be required. Candidates should have a strong background in engineering and 5+ years of validation experience.

Qualifications

• Bachelor's or Master's in Engineering or Science with relevant validation experience.
• Experience in medical devices or life sciences is preferred.
• Knowledge of GDP and FDA/Regulatory requirements.

Responsibilities

• Implement validation test matrix and develop new test equipment and methods.
• Author validation protocols, oversee testing, analyze data, and write validation reports.
• Support DOE studies and risk assessments for product development.
• Collaborate with Operations, Product Management, and Quality to enable product/process changes and qualification activities.
• Interact with cross-functional teams (R&D, Manufacturing, QA, Finance) and travel <10%.

Skills

FMEA

GDP

IQ/OQ/PQ

Minitab

DOE

Root cause analysis

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

Tools

Minitab

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 seeking a Product Validation Engineer 3.

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 < 10%

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 plus5+ years of experience with FMEA/risk analysis, product failure and root cause analysis5+ 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 repairsASQ - 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.

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!