Validation Engineer 2 - R&D

  • Bedford, MA
  • Posted 51 days ago | Updated 2 hours ago

Overview

On Site
USD 80,400.00 - 140,300.00 per year
Full Time

Skills

Value Engineering
Health Care
Life Sciences
Electronics
Employment Authorization
Mergers and Acquisitions
Recruiting
Test Strategy
Management
Test Execution
Reporting
Data Analysis
Product Design
Risk Assessment
Collaboration
Product Management
Field Marketing
Test Equipment
Research and Development
Manufacturing Engineering
EHS
Finance
Manufacturing
Chemical Engineering
Biomedical Engineering
Mechanical Engineering
Process Engineering
FMEA
Risk Analysis
Root Cause Analysis
IQ
OQ
PQ
GDP
Product Development
Design Of Experiments
Minitab
Test Methods
ISO 9000
Quality Management
Documentation
Scheme
Testing
Change Control
Chromatography
Sales
Health Insurance
Innovation
Science
MAGIC

Job Details

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 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

Who You Are

Minimum Qualifications:
  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 4+ years of experience in process development/validation

-OR-
  • Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 3+ years of experience in process development/validation
  • 3+ years of experience with FMEA/risk analysis, product failure and root cause analysis
  • 3+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

Preferred Qualifications:
  • Experienced with Product Development Process (PDP) and working on cross functional teams
  • Experience using statistical tools such as Capability, Gage R&R, DOE in Minitab
  • Capable in the development and execution of test method validations
  • Working knowledge of quality principles including ISO, Quality Management Systems, Good Documentation Practices
  • 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
  • Familiarity with change control methodology
  • Experience with MilliporeSigma filtration and chromatography products

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!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.