Equipment Validation Engineer - Medical

Job Title: Validation Engineer II

Location: Boston, MA 02127 (relocating to Braintree, MA)

Duration: 11 Months

Need locals only

Job Summary

The Validation Engineer II will be responsible for maintaining GMP-compliant facilities and equipment, ensuring all equipment meets industry standards for intended use. The role involves troubleshooting, testing, and managing equipment maintenance while collaborating cross-departmentally. The position will require on-site presence five days a week at the Boston facility, with a relocation to Braintree later in the year.

Key Responsibilities

• Author and review SOPs and Equipment Requirement Specifications.
• Manage equipment calibration, maintenance, and supplier coordination for installation and repairs.
• Perform root cause analysis for equipment failures and implement corrective actions.
• Execute Equipment Qualification Protocols and support CAPA investigations.
• Collaborate with cross-functional teams to ensure continuous improvement and compliance with regulatory standards.
  
  

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• 3 years of experience in calibration, maintenance, or related roles, ideally in a regulated industry such as pharmaceuticals or medical devices.
• Strong technical problem-solving skills and attention to detail.
• Experience with machine shop operations preferred.
  
  

Note: Candidates must be comfortable working at both the Boston and Braintree locations.

Interview Process

• 1 phone interview and 1 on-site interview.