CQV Engineer - Katalyst Healthcares & Life Sciences
Pennington, NJ 08534
About the Job
Develop and execute commissioning, qualification, and validation protocols for equipment, utilities, and facilities in line with industry regulations and client specifications.
Assist in the creation and revision of Standard Operating Procedures (SOPs) related to CQV processes, ensuring compliance with regulatory standards and industry best practices.
Collaborate with project teams to effectively integrate CQV activities into project timelines.
Provide regular updates to project teams and stakeholders through technical presentations on the status of validation activities.
Maintain high-quality standards in project execution, ensuring adherence to GMP (Good Manufacturing Practices) and regulatory guidelines.
Identify and evaluate risks associated with CQV activities and develop strategies for mitigation.
Requirements:
Bachelor's degree in engineering, science, or a related technical field.
A minimum of 5 years of experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry, commensurate with project demands.
Must be willing to work onsite in Pennington, NJ.