AstraZeneca Pharmaceuticals LP Senior Process/Reliability Engineer in West Chester, Ohio
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 PET Engineer, Bulk 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.
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
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, 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.
BS in Engineering, or related science
Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics
Minimum 4 years experience in GMP or regulated production environment
Expertise in at least one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation
Ability to develop proficiency in all of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation
Ability to coach and mentor peers
Advanced technical degree or professional certification
Proven experience leading a team of technical personnel
Uses their insight to challenge and adapt current approaches/ways of doing things
Experience in Six Sigma/ analytical trouble shooting skills
Experience working in a LEAN manufacturing environment
Next Steps – Apply today!
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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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.