Senior Equipment Qualification Engineer (GMP)

Katalyst CRO; Gresham (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks an Equipment Engineer (ECQ) to lead commissioning, qualification, and ongoing maintenance of GMP-regulated equipment and systems in our Oregon site. You will drive qualification activities, collaborate with internal teams and external service providers, and ensure regulatory compliance across projects.

This role requires 5+ years in GMP environments, strong cGMP knowledge, and proficiency in qualification documentation and change management.

Qualifications

• BS in Engineering or Science; equivalent experience considered.
• 5+ years GMP experience.
• 3+ years in equipment, facilities, or utilities qualification.
• Knowledge of cGMP, GxP, 21 CFR Part 11, CSV, and Good Documentation Practices.
• Knowledge of pharmaceutical manufacturing and laboratory systems.
• Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
• Strong written, verbal, interpersonal, organizational, and multitasking skills.
• Detail-oriented with a strong commitment to quality, safety, and compliance.

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 Subject Matter Expert (SME), when required.

Skills

GxP knowledge

Documentation skills

Detail oriented

Multitasking

Education

BS in Engineering or Science

Equivalent relevant experience

Tools

Microsoft Office

ValGenesis

Job description

Katalyst CRO seeks an Equipment Engineer (ECQ) to lead commissioning, qualification, and ongoing maintenance of GMP-regulated equipment and systems in our Oregon site. You will drive qualification activities, collaborate with internal teams and external service providers, and ensure regulatory compliance across projects.

This role requires 5+ years in GMP environments, strong cGMP knowledge, and proficiency in qualification documentation and change management.