Validation Engineer 3 - R&D

  • Bedford, MA
  • Posted 48 days ago | Updated 4 hours ago

Overview

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

Skills

PostScript
PS
Mergers and Acquisitions
Research and Development
Traceability Matrix
Test Equipment
Test Execution
Data Analysis
Product Design
Risk Assessment
Collaboration
Product Management
Field Marketing
Finance
Manufacturing
Chemical Engineering
Biomedical Engineering
Mechanical Engineering
Process Engineering
IQ
OQ
PQ
Documentation
GDP
FMEA
Risk Analysis
Root Cause Analysis
Test Methods
Minitab
Design Of Experiments
Product Development
Management
Supervision
ISO 9000
Quality Management
Scheme
Testing
Chromatography
Change Control
EHS
Human Factors And Ergonomics
URS
GAMP
Verification And Validation
Programmable Logic Controller
Sales
Health Insurance
SAP BASIS
Military
Law
Recruiting
Promotions
Human Resources
Legal
Regulatory Compliance
Reporting

Job Details

Work Location: Bedford, Massachusetts
Shift: No
Department: LS-PS-RVCN NFF & SU Chrom Validation
Recruiter: Beverly Dellisola

This information is for internals only. Please do not share outside of the organization.

Your Role:

MilliporeSigma in Bedford, MA is seeking a Validation Engineer 3. 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. You will implement an efficient and thorough validation test matrix, including development of new test equipment and test methods.

Responsibilities:
  • Authoring the validation test protocol, test execution oversight, data analysis, and authoring the validation report
  • Participate in development of the product design specifications, risk assessments, and coordinate testing for shelf-life studies
  • Planning, documenting, and executing test method validations
  • Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer application inquiries
  • Interact effectively with other groups, such as Facilities, Engineering Services, Finance, EHS & Quality

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 7+ years of experience in process development/validation

-OR-
  • Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or other Engineering field with 5+ years of experience in process development/validation
  • 5+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)
  • 5+ years of experience with FMEA/risk analysis, product failure and root cause analysis
  • 3+ years of experience in the development and execution of test method validations

Preferred Qualifications:
  • Experience using statistical tools such as Minitab for Capability analysis, Gage R&R's, & DOE's
  • Experience with Product development process and working on cross functional teams
  • Experience leading/supervising a small team
  • Working knowledge of quality principles including ISO, Quality Management Systems
  • 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
  • Experience with MilliporeSigma filtration, and chromatography products
  • Experience with change control methodology
  • Working knowledge of EHS guidelines and ergonomics principles
  • Experience with equipment development, URS, GAMP, software validation, PLC and controls, and plastics processing
  • ASQ - CQE Certification

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.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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