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Lieu: Olde West Chester, Ohio, États-Unis
ID de l'offre 12336040
Date de publication: 10/10/2019

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Description:

The Automation Engineer performs tasks related to the automation of equipment/systems for day to day manufacturing operations in the Bulk Process Execution Team (PET).  Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work.  Responsible for maintaining a strong relationship with Technical Operations and Quality areas, as well as, collaborating within the PET/Facility and with other PET Engineers.  Serves as the single point of contact for all technical issues related to automation.

Essential Job Functions:

  • Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.
  • Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment.
  • Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/ reports.
  • Coordinate and support PET’s/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence.  Manages life cycle of assets.
  • Maintain external technical relationships and collaborates with equipment and material suppliers.
  • Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.
  • Perform and maintain risk management activities for new and existing processes / equipment.
  • Initiate deviations and performs/facilitates the technical investigations and assessment of impacts.
  • Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms. 
  • Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests.
  • Provides input and develops user requirements for new asset procurement.
  • Provide engineering and project management services.
  • Assist in the development of project justification and engineering proposals including providing input for capital planning process.
  • Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.
  • Perform routine validation and periodic reviews activities.
  • Works collaboratively within PET as well as with other PET Engineers and Technology Community i.e. Technology and Engineering, global colleagues.
  • Supports and leads technical trouble shooting.
  • On-call support as required.
  • Key contact for regulatory inspections as technical process owner.
  • Participates in annual product review process.
  • Participates in biennial critical systems review process.
  • Responsible for process validation required as a result of changes to validated processes within the PET.

Minimum Requirements:

  • Bachelor's degree in Engineering required.
  • Motivated & energetic junior level engineer with a strong desire to learn automation and related equipment/systems
  • Customer oriented mindset, customer is the internal shop floor technician/operator
  • Strong ability to find practical solutions to complex problems

Preferred Background:

  • Electrical Engineer background
  • Previous experience in a regulated or cGMP environment.
  • Experience working in a LEAN manufacturing environment

Internal/External Contacts & Customers:

  • PET
  • Automation Team
  • Quality Assurance
  • Technology Community – globally
  • Regulators
  • Vendors
  • PET engineers

Reporting Relationship:

Direct Reports- 0

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Automation Engineer - Operations
Ingénierie

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