C & Q Engineer

• 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

Qualifications:

• 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.