Sr. Validation Engineer

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.

Key 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).

Key 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

Please note that this is an on-site position, with the possibility of hybrid work arrangements as the role progresses.