Equipment Engineering M/F

Job-ID32796360Reference26-01363Job 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. Support the development of equipment operational procedures. Support equipment validation activities and execute equipment qualification and validation protocols. 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. 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. Education & Experience: BS in Engineering or Science related discipline preferred; 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. 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.