C & Q Engineer

Depends on Experience

Contract: Independent, W2


    • GMP
    • Life Sciences
    • cleaning
    • cleaning validation
    • commissioning
    • computer skills
    • excellent communication
    • facility validation
    • problem - solving
    • problem - solving skills

    Job Description

    • Developing commissioning and qualification plans, protocols, and reports
    • Leading and coordinating the execution of commissioning and qualification activities
    • Conducting risk assessments and identifying potential hazards
    • Developing test scripts and performing functional testing of systems
    • Ensuring compliance with regulatory requirements and company policies
    • Collaborating with other departments such as engineering, manufacturing, and quality assurance
    • Investigating deviations, identifying root causes, and implementing corrective actions
    • Participating in audits and inspections
    • Providing technical support and guidance to colleagues and other departments


    • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field
    • Experience in commissioning and qualification activities in a regulated industry
    • Knowledge of regulatory requirements such as FDA, GMP, and ISO
    • Experience with equipment and facility validation, cleaning validation, and process validation
    • Strong analytical and problem-solving skills
    • Excellent written and verbal communication skills
    • Ability to work independently and in a team environment
    • Attention to detail and ability to manage multiple projects simultaneously
    • Strong computer skills and experience with validation software and tools

    C&Q Engineer plays a critical role in ensuring that systems and facilities meet the required standards and specifications and operate efficiently and effectively. They must have a strong understanding of regulatory requirements, excellent communication and problem-solving skills, and the ability to work collaboratively with colleagues and other departments.