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.