Validation Engineer
Location: Bedford, MA, USA
Job Number: 7545
External Description:
As a member of the R&D Validation & Applications Center (VAC) Engineering team, you actively participate on cross-functional product development teams. Your contribution includes development and implementation of an efficient and thorough validation test strategy that ensures robust product performance based on product design and intended applications. Your responsibilities include authoring the validation test protocol, overseeing test execution and authoring the report. You participate in development of the product design specifications and risks assessments and coordinate testing for shelf life studies. You are responsible for developing new test equipment and test methods and planning, documenting and executing test method validations. In addition, you collaborate with Operations, Product Management, and Field Marketing to assist with product/process change requests, raw material qualifications and customer applications. You effectively interact with other groups, such as R&D product development teams, Quality, Engineering, Facilities, EHS and Finance.
Who You Are:
Minimum Qualifications:
- Bachelor's Degree Engineering or Applied Science or related scientific discipline
- 1+ years of experience with process and product/system validations
- 1+ years of experience in Product Developement / R&D Projects / Process Engineering
- 1+ years of experience authoring formal protocols and reports utilizing Good Documentation Practices
Preferred Qualifications:
- Knowledge of quality principles including ISO, Quality Management Systems, change control
- 1+ years of experience with basic statistical analysis using Minitab
- Experience related to new product development activities and experience with FMEA/risk analysis, product failure and root cause analyses
- Proficient in Minitab utilization, including Gage R&R, DOE, capability analysis, and data analysis
- Capable in the development and execution of test method validations
- Familiarity with MilliporeSigma filtration, chromatography and Mobius products
Travel:
- Less than 10%.
Job Number: 232069
Community / Marketing Title: Validation Engineer
Location_formattedLocationLong: Bedford, Massachusetts US