Senior Packaging PET Engineer (Process Controls Engineer) - 2nd/3rd Shift

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POST DATE 9/9/2016
END DATE 10/29/2016

AstraZeneca Pharmaceuticals LP West Chester, OH

Company
AstraZeneca Pharmaceuticals LP
Job Classification
Full Time
Company Ref #
360738
AJE Ref #
576125528
Location
West Chester, OH
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Do you have a desire to join a team that is improving and enriching the lives of others? Do you have a vision to be part of a world-class manufacturer of innovative medicines for patients, and a manufacturer that is admired for its performance, its people, and its partnerships? Through your contributions you will be helping support the manufacturing of products using current Good Manufacturing Practices. You will become part of a rapidly growing team that is recognized and rewarded for their commitment. You will be working in an environment that is dynamic, entrepreneurial and fosters collaboration and innovation - and where you will make a real impact. So, be part of the team which makes us an innovation-driven, science-led company, standing firmly among the world's leaders in biopharmaceuticals. br br The Senior PET Engineer - Packing is responsible for ensuring one technical process exists within the PET/Facility. 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 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. br br Essential Job Functions: br br * 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 br * 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 br * Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the PET/Facility process br * Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/ reports br * Coordinate and support PET's/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence. Manages life cycle of assets. br * Maintain external technical relationships and collaborates with equipment and material suppliers br * Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations br * Perform and maintain risk management activities for new and existing processes / equipment br * Initiate deviations and performs/facilitates the technical investigations and assessment of impacts br * 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 br * Provides input and develops user requirements for new asset procurement br * Provide engineering and project management services br * Assist in the development of project justification and engineering proposals including providing input for capital planning process br * Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment br * Perform routine validation and periodic reviews activities br * Works collaboratively within PET as well as with other PET Engineers and br * Technology Community i.e.Technology and Engineering, global colleagues br * Supports and leads technical trouble shooting. br * On-call support as required br * Key contact for regulatory inspections as technical process owner br * Participates in annual product review process br * Participates in biennial critical systems review process. br * Responsible for process validation required as a result of changes to validated processes within the PET. br * Indirect Reports- 1-12 (mechanics, technicians, engineers) br br Internal/External Contacts & Customers: br br * PET br * Technology and Engineering br * Quality Assurance br * Technology Community -- globally br * Regulators br * Vendors br * PET engineers br br br br