Summary
As an Automation Engineer you will be part of the engineering team responsible for the design, FAT, commissioning, qualification and improvement of the Facility and Process automation systems used to support the production of biopharmaceutical drug substance during the construction and operational phases. You will be part of an exciting & motivated group and will report to the Automation Manager.
The ideal candidate will have a combined experience of biotech process automation and building management systems.
Duties and Responsibilities
Work closely with various automation, manufacturing, process engineering and IT stakeholders in order to execute the daily activities during Construction, Commissioning and Qualification phase
Manage Commissioning & Qualification activities (FAT, SAT, IQ, OQ) related to automation systems
Manage Risk analysis and DQ activities related to automation systems
Ensure that appropriate project documentation & hand-over are prepared and shared
Support the setup and maintenance of the various Facility automation systems, including the Building management systems – HVAC & Black Utilities, Process and Pure Fluids Automation
Work independently and also supervise the activities of contractors and automation vendors
Contribute to the definition of site automation standards. Develop standard operating procedures to ensure the future compliance and management of the automation systems. Work together with the team to prepare the Site Readiness.
Once the site becomes operational, handle the automation related challenges that will affect the day-to-day operation of the new bio-plant and investigate automation issues in GMP environment. Work closely with the Production team.
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines
Be open and ready to work in a demanding environment
Requirements
Engineering educational background preferably in Automation, Electrical, Bio or Chemical processing
Minimum of 7 years of experience in the biotech engineering/manufacturing environment
Demonstrated hands-on experience with various automation systems
Experience with DCS/PCS and PLC. Good knowledge of the Rockwell and Siemens platforms. The knowledge of other platforms is an advantage.
Knowledge of Virtualization of automated systems
Good knowledge of Biotech Process, Utilities and HVAC equipment
Knowledge of Single Use process automation is an advantage
Understanding of electrical standards
Good project management skills and good knowledge of Design, Construction and C&Q activities
Fluent in French and English
Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP/GAMP practices
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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