ECQ Engineer—Equipment Validation & GMP Compliance

Spectraforce Technologies; Summit (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies is hiring an Equipment Commissioning & Qualification (ECQ) Engineer for a 6-month, on-site assignment in Summit, NJ. The role centers on commissioning, qualification, and ongoing validation of equipment, facilities, and utilities within a regulated environment.

Responsibilities include protocol development, vendor supervision, and executing validation activities to deliver comprehensive documentation and reports in line with cGMP standards and 21 CFR Part 11 guidelines.

Qualifications

• Knowledge of cGMP, GXP and SDLC concepts including 21 CFR Part 11.
• Strong written and verbal communication skills for documentation and reporting.
• Experience with GMP environments and regulated pharma operations.

Responsibilities

• Develop commissioning/qualification protocols and associated reports.
• Supervise vendors for qualification tasks and manage outside resources.
• Execute equipment qualifications and validation protocols.
• Support development of equipment operation and maintenance procedures.
• Lead qualification/validation activities and create summary reports and traceability matrices.
• Maintain equipment, facilities, and utilities in compliance with policies and change control.

Skills

cGMP knowledge

Equipment qualification

Validation protocols

Vendor management

Documentation & compliance

Education

BS in Engineering or Science

Tools

Valgenesis

Microsoft Office

Job description

Spectraforce Technologies is hiring an Equipment Commissioning & Qualification (ECQ) Engineer for a 6-month, on-site assignment in Summit, NJ. The role centers on commissioning, qualification, and ongoing validation of equipment, facilities, and utilities within a regulated environment.

Responsibilities include protocol development, vendor supervision, and executing validation activities to deliver comprehensive documentation and reports in line with cGMP standards and 21 CFR Part 11 guidelines.