Senior Automation Engineer

Job Mission:

Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. 

Main Responsibilities:

• In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications.
• Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated.
• Plan in advance to ensure the availability of necessary resources, internal and/or external, by balancing resources between multiple ongoing projects, to meet plans and to deliver the expected quality on time and on budget.
• Based on acquired experience, search, define and implement the most adequate technical solutions for unexpected challenges during the construction, assembly and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality and systems.
• Participate, issue, approve and coordinate commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.) and activities
• On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations
• Execute professional activities in compliance with GMP , internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)

Profile:

• Degree in a field of equivalent qualification in Engineering (Mechanical, Electrical, Civil) or similar scientific field (mandatory)
• Experience in installation management or equipment qualification, preferably with a focus in chemical plants or Pharmaceutical industry, training and experience of GMP and HSE practices (mandatory)