Senior GMP Equipment Validation Specialist

Ushitecsolutions; Boston (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading biopharmaceutical company in Boston seeks an Equipment Validation Specialist to ensure compliance with regulatory and quality standards in biopharmaceutical manufacturing. The role involves conducting validation activities, supporting audits, and improving validation processes. The ideal candidate holds a Bachelor's degree and has over 4 years of experience in a GMP-regulated environment. Strong knowledge of GMP regulations and validation protocols is essential.

Qualifications

• 4+ years of experience in equipment validation within a biopharmaceutical or GMP-regulated environment.
• Strong understanding of GMP regulations and validation lifecycle processes.
• Knowledge of biopharmaceutical manufacturing equipment, utilities, and controlled environments.

Responsibilities

• Ensure all biopharmaceutical manufacturing equipment meets regulatory and quality standards.
• Perform validation activities including Installation Verification, Steam-In-Place, Autoclaves, and Temperature Mapping.
• Support internal and external audits with accurate validation documentation.

Skills

Equipment validation

GMP regulations

Documentation skills

Collaboration skills

Education

Bachelor’s degree in a scientific, engineering, or technical discipline

Tools

TrackWise

Laboratory Information Management System (LIMS)

Document Management System (DMS)

Job description

A leading biopharmaceutical company in Boston seeks an Equipment Validation Specialist to ensure compliance with regulatory and quality standards in biopharmaceutical manufacturing. The role involves conducting validation activities, supporting audits, and improving validation processes. The ideal candidate holds a Bachelor's degree and has over 4 years of experience in a GMP-regulated environment. Strong knowledge of GMP regulations and validation protocols is essential.