Validation Engineers III

Validation Engineers III

Worksite address: EMD Millipore Corporation, 75 Wiggins Ave., Bedford, MA 01730

Telecommuting may be permitted, so long as the employee resides within commuting distance to Bedford, MA region, as the employee must conduct regular visits to company offices in the Bedford, MA region.

Responsibilities:

1. Participate as a Core team member in Product Development projects involving filtration products (NFF or TFF Filters) which will include learning about different membranes and how they affect filter performance, and selecting the right test matrix to validate the filters. Learn various test methods like Filter integrity, Hydraulic stress test, Burst test, TOC/Conductivity test. Understand the applications of the filter to perform the functional testing on filters, learn the manufacturing process used to develop the filters and validate the equipment and process used for manufacturing filters;
2. Develop the validation strategy and test plan for Millipore filtration products as well as Single use and systems products as required by the Product development projects;
3. Author various validation protocols for different types of validations like process validation, equipment validation, system validation, packaging validation, and test method validation. Execute all tests and author the reports. Coordinate testing for shelf-life studies;
4. Author validation test summaries and product specifications for customer facing documents (Emprove Dossiers);
5. Plan, document and execute test method Validations. Collaborate with R&D engineers to plan design of experiments (DOE’s); and
6. Collaborate with Operations, Product Management, and Field Marketing to aid in product/ process change requests, raw material qualifications and customer application inquiries. Work cross functionally with Facilities, Engineering services, Finance, EHS and Quality teams.

Requirements and Qualifications:

Employer requires a Master’s degree in Mechanical Engineering, Biomedical Engineering or closely related field plus three (3) years of work experience in any occupation in an R&D environment performing process, equipment, test method and product validations. In addition, the employer requires the following:

1. Demonstrated experience as a core team member in product development process to develop new product specifications gained through three (3) years of work experience; 
2. Demonstrated experience with Design & Process FMEA’s, product failure analysis, and root cause analysis gained through three (3) years of work experience; 
3. Demonstrated experience with process, product, equipment, system, packaging, and test method validations in the Life Sciences gained through three (3) years of work experience; 
4. Demonstrated experience authoring formal protocols and reports utilizing Good Documentation Practices (GDocP) gained through three (3) years of work experience; 
5. Demonstrated experience using statistical tools for data analysis gained through three (3) years of work experience; and
6. Demonstrated experience authoring customer facing documents for product specifications and test summaries gained through three (3) years of work experience.

Alternatively, the employer requires a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or closely related field plus at least five (5) years of progressively more responsible work experience in any occupation in an R&D environment performing process, equipment, test method and product validations. In addition, the employer requires the following:

1. Demonstrated experience as a core team member in product development process to develop new product specifications gained through three (3) years of work experience; 
2. Demonstrated experience with Design & Process FMEA’s, product failure analysis, and root cause analysis gained through four (4) years of work experience; 
3. Demonstrated experience with process, product, equipment, system, packaging, and test method validations in the Life Sciences gained through four (4) years of work experience; 
4. Demonstrated experience authoring formal protocols and reports utilizing Good Documentation Practices (GDocP) gained through five (5) years of work experience; 
5. Demonstrated experience using statistical tools for data analysis gained through four (4) years of work experience; and
6. Demonstrated experience authoring customer facing documents for product specifications and test summaries gained through four (4) years of work experience.

All years of experience may be gained concurrently.

10% domestic travel and 5% international travel required per year.

This position is eligible for EMD Millipore Corporation’s Employee Referral Program.

Applicants can mail resumes to EMD Millipore Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req# 279509) or apply online at https://careers.emdgroup.com