CQV Engineer

3 months ago

College Station, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities and Requirements:
  • Develop and execute commissioning, qualification, and/or validation protocols for equipment, utilities, and/or facilities in accordance with industry regulations and client specifications.
  • Contribute to the development and revision of Standard Operating Procedures (SOPs) related to CQV processes and ensure that SOPs are in compliance with regulatory requirements and industry best practices.
  • Work collaboratively with project teams to integrate CQV activities seamlessly into project timelines.
  • Provide regular updates through technical presentations on the status of validation activities to project teams and stakeholders.
  • Uphold high standards of quality in project execution, ensuring compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
  • Identify and assess risks associated with CQV activities and develop mitigation strategies.
  • BS in Engineering, Science or equivalent technical degree.
  • Solid understanding of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively in a dynamic team environment.
  • Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.
  • Strong analytical and problem-solving skills with attention to detail.