Validation Engineer 3 - R&D

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 Validation Engineer 3.  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. You will implement an efficient and thorough validation test matrix, including development of new test equipment and test methods.

Responsibilities:

• Authoring the validation test protocol, test execution oversight, data analysis, and authoring the validation report
• Participate in development of the product design specifications, risk assessments, and coordinate testing for shelf-life studies
• Planning, documenting, and executing test method validations
• Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer application inquiries
• Interact effectively with other groups, such as Facilities, Engineering Services, Finance, EHS & Quality

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, or other Engineering field with 7+ years of experience in process development/validation

-OR-

• Master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 5+ years of experience in process development/validation

• 5+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

• 5+ years of experience with FMEA/risk analysis, product failure and root cause analysis
• 3+ years of experience in the development and execution of test method validations

Preferred Qualifications:

• Experience using statistical tools such as Minitab for Capability analysis, Gage R&R’s, & DOE’s

• Experience with Product development process and working on cross functional teams
• Experience leading/supervising a small team
• Working knowledge of quality principles including ISO, Quality Management Systems
• Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements (CB Scheme/ UL testing) for systems used in biopharmaceutical processes
• Proficiency in equipment calibration, trouble shooting and repairs
• Experience with MilliporeSigma filtration, and chromatography products
• Experience with change control methodology
• Working knowledge of EHS guidelines and ergonomics principles
• Experience with equipment development, URS, GAMP, software validation, PLC and controls, and plastics processing
• 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.

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!