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Equipment Engineer

Karwell Technologies

  • Summit, NJ
  • 30+ days ago

    Highlights

    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. 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.

    Numbers & Facts

    LocationSummit, NJ

    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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