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Commissioning and Qualification Specialist
Il y a 2 mois
At TMC, we are seeking a highly skilled Commissioning Engineer to join our team. As a Commissioning Engineer, you will play a crucial role in ensuring the smooth operation of our pharmaceutical facilities.
Key Responsibilities:- Perform commissioning and qualification activities in accordance with Good Manufacturing Practices (GMP) and industry best practices.
- Support commissioning and qualification activities, including design reviews and documentation.
- Stay up-to-date with training on GMP procedures and best practices.
- Develop commissioning and qualification master plans and system-specific plans as required.
- Develop system-level impact assessments and component classification documents.
- Review equipment specifications to ensure FAT, SAT, and PIM requirements are included.
- Facilitate and document design reviews and design qualifications.
- Support FAT and SAT activities, including receipt verification for components and equipment.
- Develop and execute commissioning documentation, including installation verification, start-up, loop checks, initial calibration, and functional testing.
- Develop and execute IQ and OQ documentation.
- Collaborate with automation contractors to support integrated C&Q/CSV approaches.
- Provide monthly status and budget updates to the C&Q Lead using a C&Q monthly report template.
- BS Engineering or equivalent experience.
- 5 years of experience working in a pharmaceutical environment, preferably in a sterile process.
- 10 years of commissioning and qualification experience.
- Demonstrated leadership and people management skills.
- Knowledge of GMPs, regulatory requirements, equipment commissioning, and qualification.
- Excellent written and verbal communication skills in French and English.
