About this opportunity
JobDiva, Inc. lists this Equipment Engineer opportunity in gresham, Oregon. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
gresham, OR, 97080, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.