Engineer, Validation

Job description:

Duties & Responsibilities:

 

  • Manage qualification, validation, and calibration processes and protocols/reports (prepare, review, approve, execute) for plant and facility systems.
  • Generate, review, and approve standard operating procedures (SOPs), risk assessment reports, and deviation reports.
  • Ensure adherence to GMP/GLP compliance and data integrity guidelines.
  • Collaborate with cross-functional teams to support validation activities and resolve any issues that arise.
  • Conduct equipment validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Perform regular assessments and maintenance of validated systems to ensure continued compliance.
  • Develop and maintain validation master plans and protocols for new equipment and systems.
  • Provide training and support to staff on validation processes and equipment operation.
  • Participate in audits and inspections related to validation activities.
  • Analyze and document validation results, ensuring accurate reporting and compliance with regulatory standards.

 

Qualifications:

 

  • Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Mechatronics).
  • 1.5 to 3 years of experience in a facilities or systems environment, performing analyses and working with relevant instrumentation.
  • Strong knowledge of validation methodologies and regulatory requirements (e.g., FDA, WHO, ISPE, etc.).
  • Familiarity with quality management systems and documentation practices.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
  • Proficiency in using validation tools and software.
  • Proficiency in English, both written and spoken, is required.
  • Certification in validation or quality assurance is a plus.
تاريخ النشر: ١٤ أكتوبر ٢٠٢٤
الناشر: LinkedIn
تاريخ النشر: ١٤ أكتوبر ٢٠٢٤
الناشر: LinkedIn