Validation Engineer

Company: Collabera
Location: Burlington
Posted on: May 28, 2023

Job Description:

Minimum Qualifications:
B.S. in Engineering or Applied Science or equivalent, and 1-5+ years of experience in process development or validation engineering.
M.S. in Engineering or Applied Science or equivalent, and 1-3+ years of experience in process development or validation engineering.
1-5+ years of experience with process and product/system validations (IQ/OQ/PQ)
1-5+ years of experience in equipment calibration, troubleshooting and repairs
Must have risk assessment, risk management experience.
Detailed knowledge of FDA, GMP, IEEE 1012, ISO 13485 and IEC 62304
CAPA ecperience.
Preferred Qualifications:
Experienced with Product Development Process (PDP)
Familiarity with FMEA/risk analysis, product failure and root cause analysis
Experience authoring formal protocols and reports utilizing Good Documentation Practices.
Working knowledge of quality principles including ISO, Quality Management Systems
Experience using statistical tools such as Gage R&R, DOE, capability analysis, and data analysis in Minitab and or Excel.
Capable in the development and execution of test method validations
Locations:
MA, GA, MN, IL, CA, TX, WA, MD
Pay range:
35-55/Hr
PDN-993757b2-d29e-4674-b4eb-d9283d5800f0

Keywords: Collabera, Burlington , Validation Engineer, Engineering , Burlington, North Carolina