Sr. Validation Engineer
About The Position
EQVAL Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ). We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service. We are seeking a Sr. Validation Engineer with at least five (5) years of experience in Computerized System and Process Validation. The ideal candidate has hands-on experience with URS, FAT, IQ/OQ/PQ, automated equipment, and validation documentation within Medical Device or Pharmaceutical environments.
Requirements
- Bachelor’s Degree in Engineering
- Minimum of 5 - 7 years of experience in: Computerized System Validation (SRS, URS, FAT, IQ, Source Code) Process Validation (PDR, OQ/PQs)
- Experience with automation and validation of highly complex equipment, including documentation.
- Hands-on experience in troubleshooting, debugging, and technical issue resolution.
- Proficiency in 21 CFR Part 820 and Minitab.
- Strong project management and technical writing skills.
- Fully bilingual (English and Spanish).
Responsibilities
- Provide production support engineering for testing methods and procedures.
- Address device specification and yield issues.
- Optimize device production while considering cost constraints.
- Manage device manufacturing after high-volume production transfer.
- Assist customers with device usage and testing.
Benefits
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Vision insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
