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Commissioning & Quality Engineer

Salary undisclosed

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The Commissioning & Quality Engineer is responsible for the installation, commissioning, and validation of manufacturing systems, equipment, and processes, ensuring they meet regulatory standards such as FDA, GMP, and ICH guidelines.

Qualifications:

  • Bachelor’s degree in engineering (Pharmaceutical, Chemical, Mechanical, Electrical, or related field).
  • 5-10 years of experience in commissioning, validation, and quality assurance within the pharmaceutical or related regulated industries.
  • Maintain and manage detailed documentation on the commissioning, qualification, and validation processes
  • Experience in qualification/validation processes (IQ, OQ, PQ) for pharmaceutical equipment, utilities, and systems.
  • Provide technical support and advice during the commissioning process, ensuring smooth collaboration between internal and external teams (e.g., vendors, contractors).
  • Participate in the review and approval of commissioning and qualification documents and ensure alignment with GMP and regulatory guidelines.
  • Knowledge of quality management systems and the ability to apply them effectively in a regulated environment.
  • Proficient in using validation/commissioning software and systems.
  • Strong troubleshooting, problem-solving, and analytical skills.

The Commissioning & Quality Engineer is responsible for the installation, commissioning, and validation of manufacturing systems, equipment, and processes, ensuring they meet regulatory standards such as FDA, GMP, and ICH guidelines.

Qualifications:

  • Bachelor’s degree in engineering (Pharmaceutical, Chemical, Mechanical, Electrical, or related field).
  • 5-10 years of experience in commissioning, validation, and quality assurance within the pharmaceutical or related regulated industries.
  • Maintain and manage detailed documentation on the commissioning, qualification, and validation processes
  • Experience in qualification/validation processes (IQ, OQ, PQ) for pharmaceutical equipment, utilities, and systems.
  • Provide technical support and advice during the commissioning process, ensuring smooth collaboration between internal and external teams (e.g., vendors, contractors).
  • Participate in the review and approval of commissioning and qualification documents and ensure alignment with GMP and regulatory guidelines.
  • Knowledge of quality management systems and the ability to apply them effectively in a regulated environment.
  • Proficient in using validation/commissioning software and systems.
  • Strong troubleshooting, problem-solving, and analytical skills.