Location:West Chester, United StatesJob reference:
Dec. 01, 2016
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
our the Process Execution Team(PET) in West Chester, Ohio, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Main Duties and Responsibilities
This is a Blended Role therefore you will focus on packaging material engineering, other areas exposed to are as follows: automation engineering, production/ process engineering, packaging equipment engineering, validation engineering, and related levels. In this role you will be assigned to a specific shift.
As the Shift Engineer you will be responsible for ensuring one technical process exists within the PET /Facility. This includes equipment, materials, process, and procedures with applicable validation. You will lead continuous improvement initiatives as the technical expert and acts as the first line of support for all project related work. Also in this role, you will be 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. You will also serves as the single point of contact for all technical packaging issues.
- 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 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 (e.g., packaging)
- 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 (e.g., new package introductions, etc.) / equipment
- Initiate deviations and performs/facilitates the technical investigations and assessment of impacts (e.g., related to packaging materials)
- Authors and review documents including Standard Operating Procedures (SOPs), 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 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)
- Supports and leads technical trouble shooting (e.g., packaging materials, etc.,)
- 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.