Equipment Engineer

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

• The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
• The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.
• 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.
• 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.

Job Summary

• The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
• The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.

Roles & 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.

Education & Experience:

• BS in Engineering or Science related discipline preferred; equivalent relevant experience may be considered.
• Minimum of 5 years of experience performing or supporting activities 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, Computer System Validation (CSV) requirements, 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.
• Ability to manage multiple projects and prioritize tasks effectively.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
• Experience with Electronic Data Management Systems such as ValGenesis is preferred.