Validation Engineer 2

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 Validation Engineer 2.  As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate on product development teams. 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, 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 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, Engineering Services, Facilities, EHS, and Finance

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in an Engineering or Applied Science field with 3+ years of experience in product/process development or validation engineering

 -OR-

• Master’s degree in an Engineering or Applied Science field with 2+ years of experience in product/process development or validation engineering
• 2+ years of experience with FMEA/risk analysis, product failure, and root cause analysis
• 2+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice

Preferred Qualifications:

• Understanding of quality principles including ISO, Quality Management Systems, Good Documentation Practices, and tools including FMEA, risk analysis, and root cause analysis
• Experience with Product Development Process (PDP) or a similar full life cycle product development process
• Experience with product/process/software/automated system validation
• Knowledge of applicable FDA Regulations and regulatory requirements for products used in biopharmaceutical processes
• Experience in Product Quality as it related to Product Design or Product Manufacturing
• Familiarity with change control methodology
• Experience in the development and execution of test methods and validations
• Self-motivated, enthusiastic, and able to interact effectively with people in all areas of the company including Plant Operations, R&D, Quality, and Product Management
• Experience using statistical tools such as Gage R&R, DOE, Cpk, and data analysis in Minitab or equivalent
• Excellent written and verbal communication skills  

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html