Description

As a C&Q Engineer, you will engage in validation and qualification activities, ensuring compliance with regulations while managing risk assessments and continuous improvement efforts. This role involves collaborating with teams, coordinating audits, and maintaining effective relationships to support equipment and system integrity.

Requirements

• •BS/MS in Engineering/Technical discipline or equivalent experience
• •Minimum 1 year of experience in the pharmaceutical industry
• •Strong knowledge of international regulatory regulations, cGxP requirements, and best practices
• •Proactive and collaborative communication skills
• •Problem identification and solution recommendation skills
• •Team player with effective interaction skills
• •Good level of English
• •Ability to communicate in French preferred

Tasks

• •Perform validation and qualification activities
• •Ensure compliance with cGMP and internal policies
• •Develop and justify the C&Q approach based on risk and scientific rationale
• •Manage continuous improvement topics in equipment risk analysis
• •Lead risk assessments and periodic review activities
• •Ensure qualification and validation of equipment and systems
• •Author and review qualification documents as needed
• •Execute re-qualification and periodic review activities
• •Contribute to the development of local site procedures
• •Review change controls and maintenance interventions
• •Coordinate qualification and validation execution activities
• •Participate in internal and external audits as a subject matter expert
• •Establish effective relationships with internal teams, customers, and suppliers
• •Proactively identify problems and propose solutions
• •Complete work independently while seeking guidance on complex tasks
• •Participate in projects and initiatives as directed