GMP Equipment Qualification Engineer

Creative Solutions Services, LLC; Summit (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an Equipment Engineer specializing in ECQ to support commissioning, qualification, and validation of pharmaceutical equipment within a GMP environment. The role ensures equipment remains commissioned and qualified and collaborates with internal teams and external providers on implementation projects.

The position emphasizes developing protocols, supervising qualification work, and maintaining documentation in line with regulatory standards.

Qualifications

• BS in Engineering or Science or equivalent experience.
• Minimum 5 years in a GMP environment.
• Minimum 3 years in equipment, facilities, or utilities qualification.
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, CSV, and Good Documentation Practices.
• Understanding of investigations, deviations, and CAPA in pharma.

Responsibilities

• Maintain commissioned/qualified equipment, facilities, and utilities in compliance.
• Develop commissioning/qualification protocols and reports.
• Supervise vendors performing qualification activities.
• Support development of equipment operational procedures.
• Execute equipment qualification and validation protocols.
• Prepare Validation Plans, Requirements Specifications, Design Specs, Traceability Matrices, and Summary Reports.
• Assist Change Management processes.
• Support equipment implementation projects from scheduling to turnover.
• Oversee operation, calibration, and preventive maintenance.
• Complete qualification and validation documentation accurately and in compliance.

Skills

GMP experience

Documentation practices

Written and verbal communication

Multitasking

Project management

Education

BS in Engineering or Science

Equivalent relevant experience

Tools

ValGenesis

Database systems

Microsoft Office Suite

Job description

Creative Solutions Services, LLC is seeking an Equipment Engineer specializing in ECQ to support commissioning, qualification, and validation of pharmaceutical equipment within a GMP environment. The role ensures equipment remains commissioned and qualified and collaborates with internal teams and external providers on implementation projects.

The position emphasizes developing protocols, supervising qualification work, and maintaining documentation in line with regulatory standards.