Product Validation Engineer 2 - R&D

The businesses of Merck KGaA, Darmstadt, Germany•Bedford, MA

About The Position

MilliporeSigma in Bedford, MA is hiring a Product 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.

Requirements

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 4+ 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 3+ years of experience in process or product development/validation
2+ years of experience with FMEA/risk analysis, product failure and root cause analysis
3+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

Nice To Haves

Experience in Medical Device or Life Science industries
Experience with filtration and chromatography products
Experience with Product Development Process (PDP) and working on cross functional teams
Experience in statistical analysis tools such as Capability, Gage R&R, DOE using Minitab
Capable in the development and execution of test method validations
Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry
Experience in equipment trouble shooting and repairs

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 <10%