Product Validation Engineer 3 - R&D

MilliporeSigma; Bedford (MA); On-site; USD 80,000 - 140,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

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

This role requires deep experience in validation, testing, and cross-functional collaboration across Quality, Manufacturing, and Engineering. Travel<10% may be required.

Qualifications

• 7+ years of experience in process or product development/validation.
• Experience with FMEA/risk analysis and root-cause analysis.
• Experience with IQ/OQ/PQ validations and GDP documentation.
• Knowledge of applicable FDA regulations, USP requirements and regulatory aspects for biopharmaceutical/medical device products.
• ASQ CQE certification is a plus.

Responsibilities

• Implement an efficient validation test matrix including development and validation of test equipment and methods.
• Author validation protocols, oversee test execution, analyze data and write the validation report.
• Support DOE studies, data analyses, design specs and risk assessments for products.
• Collaborate with Operations, Product Management and Field Marketing on change requests, qualifications, shelf-life studies, and customer inquiries.
• Interact with R&D, Quality, Manufacturing, Engineering Services, Facilities, EHS and Finance on validation activities.

Skills

Process validation

Product development

FMEA

GDP

IQ/OQ/PQ

DOE studies

Root-cause analysis

Education

Bachelor's degree in Chemical Engineering or related field

Master's degree in Chemical Engineering or related field

Tools

Minitab

Gage R&R

DOE

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. 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 <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 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.

RSREMD

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!