We are looking for a CQV Lead with
expertise in production equipment such as isolators, bioreactors, fume hoods,
BSCs, and TCUs. The candidate will be responsible for protocol development and
execution to ensure production equipment meets operational and regulatory
standards.
• Develop and execute commissioning, qualification, and validation protocols for
production equipment.
• Coordinate with equipment vendors for FAT/SAT activities and ensure integration
into facility systems.
• Oversee equipment calibration, performance verification, and documentation.
• Lead risk assessments to identify and mitigate potential equipment compliance
risks.
• Provide cross-functional support for other CQV efforts within the project.
• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in validating production equipment in pharmaceutical
environments.
• Expertise in isolators, bioreactors, fume hoods, and other lab equipment.
• Strong knowledge of regulatory requirements and risk-based validation
approaches.
• Excellent project management and problem-solving skills.