GMP Equipment Engineer – Commissioning & Qualification

JobDiva, Inc.; Gresham (OR); On-site; USD 110,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC in the United States is seeking an Equipment Engineer focused on ECQ to support commissioning, qualification, and maintenance of critical equipment in a GMP environment.

You will develop protocols, supervise vendors, drive validation activities, and ensure compliance with cGMP and 21 CFR Part 11 while collaborating with internal teams and external service providers. This role emphasizes documentation, change control, and readiness for regulatory inspections.

Qualifications

• BS in Engineering or science field; equivalent relevant experience may be considered.
• Minimum of 5 years of experience in a GMP environment.
• Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, CSV and Good Documentation Practices.

Responsibilities

• Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
• Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
• Supervise vendors performing qualification activities.
• Support the development of equipment operational procedures.
• Support equipment validation activities and execute equipment qualification and validation protocols.
• Develop validation and qualification deliverables, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
• Support the Change Management process.
• Support equipment implementation projects, including scheduling, site preparation, installation, qualification, and turnover to business.
• Support operation, calibration, and preventive maintenance of equipment to meet business requirements.
• Complete qualification and validation documentation accurately and in compliance with client standards.
• Review, prioritize, and respond to customer equipment qualification and support requests.
• Provide technical support and guidance on equipment qualification issues.
• Interface with customers to ensure expectations are met.
• Provide technical support for equipment, utilities, facilities, and computerized systems qualification and validation issues.
• Maintain positive working relationships with team members and site customers.
• Ensure equipment, facilities, and programs remain compliant with regulatory requirements.
• Participate in deviation investigations as a SME, when required.

Skills

Equipment qualification

Validation protocols

Vendor management

Education

Bachelor's degree in Engineering or Science

Tools

ValGenesis

Microsoft Office

Job description

Creative Solutions Services, LLC in the United States is seeking an Equipment Engineer focused on ECQ to support commissioning, qualification, and maintenance of critical equipment in a GMP environment.

You will develop protocols, supervise vendors, drive validation activities, and ensure compliance with cGMP and 21 CFR Part 11 while collaborating with internal teams and external service providers. This role emphasizes documentation, change control, and readiness for regulatory inspections.