Onsite GMP Equipment Commissioning & Qualification Engineer

SOKOL GxP Services; Summit (NJ); On-site; USD 77,000 - 83,000; Part time

Benefits offered by this job

Health insurance with dental andVision

Holiday pay

401(k) program

Employee referral bonus program

Possible contract extension

Job summary

SOKOL GxP Services is seeking an Equipment Commissioning & Qualification Engineer to support implementation, qualification, validation, and compliant operation of equipment at a GMP-regulated pharmaceutical site in Summit, NJ. The role involves developing commissioning and qualification protocols and coordinating external vendors from installation to turnover.

The position requires 5+ years in GMP environments, 3+ years in qualification, and strong documentation skills.

Qualifications

• Minimum of 5 years of experience performing or supporting activities in a GMP-regulated environment.
• Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
• Experience developing and executing commissioning, qualification, or validation protocols and associated reports.
• Experience preparing qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, computerized systems validation requirements, and good documentation practices.

Responsibilities

• Develop and execute commissioning and qualification protocols for equipment, facilities, or utilities.
• Prepare validation and qualification documentation.
• Coordinate external vendors and support equipment implementation from installation through qualification and turnover.
• Support change management, equipment lifecycle activities, and deviation investigations as needed.
• Supervise vendors and manage multiple projects in a fast-paced environment.

Skills

GMP-regulated environment

Equipment qualification

Vendor supervision

Project management

Documentation & reporting

MS Word/Excel/PowerPoint

Education

Bachelor’s degree in Engineering or related discipline

Tools

ValGenesis

Job description

SOKOL GxP Services is seeking an Equipment Commissioning & Qualification Engineer to support implementation, qualification, validation, and compliant operation of equipment at a GMP-regulated pharmaceutical site in Summit, NJ. The role involves developing commissioning and qualification protocols and coordinating external vendors from installation to turnover.

The position requires 5+ years in GMP environments, 3+ years in qualification, and strong documentation skills.