Qualification Engineer

2 months ago

Morris Plains, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities and Requirements:
  • Education: A bachelor's or master's degree in engineering, preferably in chemical or mechanical engineering, or a related field.
  • Experience: 5+ years of relevant experience in the pharmaceutical industry, with a focus on CQV activities. This experience should include hands-on experience in executing validation protocols but is focused more on the development of these documents for equipment qualification, and commissioning activities.
  • Expertise in regulatory requirements : Strong knowledge and understanding of FDA regulations, GMP (Good Manufacturing Practices), and other relevant regulatory guidelines applicable to the pharmaceutical industry.
  • Validation and qualification experience : Extensive experience in developing and executing validation protocols, including equipment, facilities and utilities qualification.
  • Project management skills: Ability to effectively manage and lead CQV projects, including developing project plans, coordinating with cross-functional teams, ensuring adherence to timelines, and delivering projects within budget.
  • Technical skills : Proficiency in utilizing various CQV tools, methodologies, and techniques, such as risk assessments, validation master plans, validation protocols, and data analysis. Familiarity with computerized systems validation (CSV) and automated systems is a plus.
  • Leadership and communication: Strong leadership skills, with the ability to effectively communicate and collaborate with cross-functional teams, stakeholders, and clients. Excellent oral and written communication skills are necessary for preparing reports, presenting validation findings, and training personnel.
  • Problem-solving and critical thinking : Strong analytical and problem-solving skills to identify and resolve deviations in a timely manner and ensure compliance with regulatory requirements.
  • Quality mindset: A strong commitment to quality and compliance, with an understanding of quality systems and continuous improvement concepts like Lean Six Sigma.

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