CQV Engineer

4 weeks ago

Singapore Anter Consulting Pte. Ltd Full time
Job Summary:
The Commissioning, Qualification, and Validation (CQV) Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of pharmaceutical manufacturing processes and facilities. The ideal candidate will be responsible for planning, executing, and documenting the validation activities in compliance with regulatory requirements, industry standards, and company policies.

Key Responsibilities:

  • Develop and execute commissioning, qualification, and validation protocols for pharmaceutical manufacturing equipment, facilities, and utilities.
  • Perform risk assessments and impact assessments for validation activities to ensure product quality, safety, and compliance with regulatory requirements.
  • Prepare and review Standard Operating Procedures (SOPs) related to CQV activities.
  • Manage the execution of IQ, OQ, and PQ activities for equipment and facilities to ensure compliance with regulatory requirements and company standards.
  • Review and analyze validation data to ensure compliance and identify deviations or discrepancies.
  • Troubleshoot issues and deviations during the validation process and implement corrective and preventive actions (CAPAs) as needed.
  • Participate in cross-functional teams and work collaboratively with other departments to ensure successful project execution.
  • Maintain up-to-date knowledge of regulatory guidelines, industry standards, and best practices related to CQV in the pharmaceutical industry.
  • Assist in preparing and maintaining validation master plans and project plans.
  • Ensure that all CQV activities are carried out in a safe and environmentally responsible manner.

Qualifications:

  • Bachelor's or Master's degree in engineering, pharmaceutical sciences, or a related field.
  • Minimum of 3 years of experience in pharmaceutical CQV, with a strong understanding of regulatory requirements (e.g., FDA, EMA, ICH).
  • Knowledge of GMP, GLP, and GAMP guidelines.
  • Strong analytical, problem-solving, and documentation skills.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Project management experience is a plus.
  • Relevant certifications (e.g., ASQ, ISPE) are a plus.

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