What are the responsibilities and job description for the Equipment Engineer position at Katalyst CRO?
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.
- 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.
- 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.