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Commissioning and Qualification Specialist
Il y a 2 mois
We are seeking a highly skilled Commissioning and Qualification Engineer to join our team at TMC.
Your Key ResponsibilitiesAs a Commissioning and Qualification Engineer, you will be responsible for:
- Performing C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
- Supporting C&Q activities.
- Staying current on training of GFD procedures and best practices.
- Developing Commissioning and Qualification Master Plans (CQMP) and system-specific plans, if required.
- Developing System Level Impact Assessment documents.
- Developing component classification documents.
- Developing User Requirement documents, if required.
- Reviewing equipment specifications to ensure FAT, SAT, and PIM requirements are included, as appropriate.
- Facilitating and documenting Design Reviews and Design Qualifications.
- Supporting FAT and SAT activities.
- Performing receipt verification for components and equipment delivered to site.
- Developing and executing commissioning documentation (e.g., installation verification, start-up, loop checks, initial calibration, functional testing).
- Developing and executing IQ and OQ documentation.
- Collaborating with Automation contractors in support of integrated C&Q/CSV approach.
- Providing monthly status and budget updates to C&Q Lead using C&Q monthly report template.
We are looking for a candidate with:
- BS Engineering (or equivalent experience).
- 5 years working in a pharmaceutical environment and, if possible, in a sterile process.
- 10 years C&Q experience.
- Demonstrated leadership and people management skills.
- Knowledge of GMPs, regulatory requirements, equipment commissioning, and qualification.
- Good written and verbal communication skills with both technical and non-technical staff (French + English).
