GMP Validation & Equipment Lifecycle Specialist

Vector BioMed, Inc.; Gaithersburg (MD); On-site; USD 85,000 - 115,000; Full time

Job summary

Vector BioMed, Inc. seeks an Engineering Technical Specialist to provide direct and indirect technical support for GMP and Non-GMP operations across process development, clinical, and manufacturing.

The role covers validation, metrology, and facilities maintenance for equipment and systems to ensure quality and reliability. You will develop validation documentation (IORQ/IOPQ), execute protocols, address deviations, and prepare final reports.

Qualifications

• Bachelor’s degree in science or related discipline preferred but professional experience may substitute.
• 3+ years of recent experience in metrology, facilities maintenance, or Electronic Maintenance System.
• Good understanding of cGMPs, regulatory requirements, and quality systems.
• Strong written and verbal communication.
• Proficient in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).

Responsibilities

• Develop, validate, and document protocols including IOPQ.
• Execute protocols, address deviations, and finalize reports.
• Coordinate scheduling with stakeholders and ensure documentation closure.
• Review and approve validation documents and calibration reports.
• Oversee vendor qualification and service work orders where applicable.
• Respond to building/equipment alarms and perform simple calibrations as needed.
• Develop and manage work orders (corrective and preventive).
• Maintain eQMS lifecycle and onboard/offboard equipment/systems.

Skills

Metrology

Facilities maintenance

Electronic Maintenance System

Education

Bachelor's degree in science

Tools

Microsoft 365

Job description

Vector BioMed, Inc. seeks an Engineering Technical Specialist to provide direct and indirect technical support for GMP and Non-GMP operations across process development, clinical, and manufacturing.

The role covers validation, metrology, and facilities maintenance for equipment and systems to ensure quality and reliability. You will develop validation documentation (IORQ/IOPQ), execute protocols, address deviations, and prepare final reports.