Process Engineer, Multidiscipline

Job Description Summary

The Process Engineer, Multidiscipline is responsible for support in execution of engineering processes/activities within an aseptic environment (design, implementation, maintenance, etc.) by providing a technical area of expertise while using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives in accordance with the law, internal regulations. Responsible for reliable, efficient and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.

 

Job Description

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Supply Chain professionals to help us reach our ambitious goals.

Location: Onsite

Your responsibilities include, but are not limited to:

• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
• Set-up maintenance for new equipment (incl. spare part needs).
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Provides hands-on support and oversight of installation, maintenance, troubleshooting, and repair of assets and systems which support the manufacturing facility.
• Creates, reviews, and approves critical documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals.
• Perform GMP risk assessments (incl. Sensors SRA).
• Independently leads and/or provide SME-level support on all phases of projects, from identification to close out.
• Ensures new equipment is appropriately designed/commissioned/qualified and existing processes run in a compliant manner throughout the equipment lifecycle.
• Support internal and external audits.
• Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
• Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning & qualification activities as required.
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs
• Leads small teams to advance facility and equipment changes in line with 5- and 10-year strategic plans.
• Complete and provide accurate documentation, as required in cGMP …