Automation Lead
Job ID SR0048358 Date posted 04 / 24 / 2020 Location Santa Rufina, Italy; Rieti, Italy
Thecandidatewill responsible of :
Ensuring reliability and efficiency of computerized systems supporting manufacturing operations and full adherence of plant computerized systems to EU Annex 11 and CFR21 part 11 requirements
Providing managerial direction and technical leadership for the design and development of automation and control systems, including engineering, startup, commissioning and support to qualification
Adopting state of the art technology in the development of computerized systems to sustain plant strategic projects and increase efficiency of manufacturing processes
Leading the site digital master plan to enable the Industry transformation
Harmonizing global standards in the design, qualification and management of plant computerized systems
Ensuring the widest availability of manufacturing and process data to relevant plant functions
Leading automation engineers responsible for supervising the design, startup, and maintenance of the automation systems.
Providing support for end users through life-cycle document reviews, training, and hand over of systems to operations.
Bachelor’s degree is required in electronic / electrical Engineering or related engineering field.
Multi year experience in pharmaceutical / biotech operations, with working knowledge of cGMPs, FDA regulatory guidelines andvalidation principles are required.
Design experience or owners experience in control systems for HVAC, plant utilities, clean utilities and process equipment.
Expertise of process systems including PLC, HMI, SCADA, MES applications.
Fluent in Englishlanguage
Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to interact with multi-disciplinary teams.
Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to lead direct reports, as well as interface across management levels and departments.
Strong self accountability and result orientation.