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Lieu: Olde West Chester, Ohio, États-Unis
ID de l'offre 11994390
Date de publication: 05/23/2019

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.

The Senior Packaging Engineer is responsible as an overall accountable single point of contact for all technical packaging issues while ensuring a technical process exists within the Packaging Department.   This includes equipment, materials, process, and procedures with applicable validation.  Leads improvement initiatives as the technical expert and acts as the first line of support for all Packaging 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. 

Essential Job Functions:

  • Ensures there are clear technical packaging processes with critical process parameters, material fit for use and operating procedures necessary to meet the process.
  • Supports and leads technical trouble shooting and provides on-call support for 24/7 operation.
  • Leads the following continuous process improvement efforts related to packaging materials: changeover reduction, yield improvements, OEE improvement and waste reduction for improvement of automated pharmaceutical manufacturing equipment
  • Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the PET/Facility process
  • Generates a variety of URS (User Requirements Specification), FAT (Factory Acceptance Test), SAT (Site Acceptance Test), commissioning and IQ (Installation Qualification) /OQ (Operational Qualification) / PQ (Performance Qualification) protocols/ reports
  • Coordinate and support PET’s/Facility improvement initiatives and develops and maintains the master plan for packaging equipment that includes the life cycle of the 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 packaging introductions and equipment 
  • Initiate deviations and performs/facilitates the technical investigations and assessment of impacts related to packaging materials and the packaging process.  
  • Authors and review documents including Standard Operating Procedures (SOPs), Batch Records, Rework procedures and other forms. 
  • Author, review and approve engineering studies, validation protocols and change control documents.
  • Provides input and develops user requirements for new asset procurement
  • Provide packaging 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)

  • Key contact for regulatory inspections as technical process owner
  • Participates in pFMEA’s and critical systems and annual product review processes

Minimum Requirements:

  • BS in Engineering, or related science
  • Experience in GMP or regulated production environment
  • Experience in packaging material development and use as related to existing and new products.
  • Problem solving experience

Preferred Background:

  • BS in Packaging or other Engineering, or related science

  • Strong verbal and written communication skills
  • Proven ability to work effectively in a team environment
  • Ability to generate and interpret technical documents
  • Experience managing external technical relationships
  • Experience working in a LEAN manufacturing environment
  • Technical packaging-specific manufacturing operations experience. 

  • GMP experience is strongly preferred, to include validation, change control, CAPA/Deviation. 

  • Continuous improvement mindset is a plus

  • Some demonstrated operations OEE Improvement results.

  • First line management experience is also a plus.

Additional Preferred Experience:

  • -Automation experience
  • -SAP
  • -Trackwise
  • -Maintenance optimization
  • -Team based approach / collaboration skills
  • -5S

Travel Requirements / Work Times:

  • 5 % Travel for Vendor and Supplier Visits and Meetings
  • Work Times: Day Shift Monday-Friday.  Also requires potential on-call support, weekend and off shift hours to support projects or the 24/7 operation.

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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

Senior Packaging Engineer - Operations

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