ECQ Engineer: Equipment Commissioning & Validation

ECLARO; Summit (NJ); On-site; USD 84,000 - 90,000; Full time

Benefits offered by this job

401k Retirement Savings Plan

Commuter Benefits

Medical/Dental/Vision Insurance

Job summary

ECLARO is seeking an Equipment Commissioning & Qualification (ECQ) Engineer for its client in Summit, NJ. The role focuses on commissioning, qualification and maintenance of equipment, facilities, and utilities in a GMP environment.

You will develop qualification protocols, supervise vendors, and support validation activities while adhering to regulatory requirements and company policies. Strong communication and multi-tasking are essential.

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Understanding of GMP manufacturing and laboratory systems and CAPA management.
• Strong written and verbal communication skills and ability to handle multiple projects.
• Experience with Electronic Data Management Systems such as Valgenesis is preferred.
• Minimum of 5 years in a GMP environment and 3 years in equipment/utility qualification.

Responsibilities

• Commissioning and Qualification activities for equipment, facilities and utilities, including development of protocols and reports.
• Supervise vendors for qualification functions and support validation deliverables.
• Manage projects of limited scope, coordinating with internal customers and external service providers.
• Provide technical support on qualification issues and ensure regulatory compliance.
• Maintain strict adherence to change management and documentation practices.

Skills

cGMP knowledge

Regulatory knowledge

Communication skills

Multitasking

Team collaboration

Computer literacy

Quality focus

Education

BS in Engineering or Science

Tools

Valgenesis

Job description

ECLARO is seeking an Equipment Commissioning & Qualification (ECQ) Engineer for its client in Summit, NJ. The role focuses on commissioning, qualification and maintenance of equipment, facilities, and utilities in a GMP environment.

You will develop qualification protocols, supervise vendors, and support validation activities while adhering to regulatory requirements and company policies. Strong communication and multi-tasking are essential.