Senior Manufacturing Engineer, Filling - Operations
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.
Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events.
The Senior Manufacturing Engineer (Monday-Friday days) 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 PT&D 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.
What you’ll do:
- 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 such as Technology and Engineering, global colleagues.
- Supports and leads technical trouble shooting and provides on-call support as required.
- Key contact for regulatory inspections as technical process owner.
- Participates in annual product review process and participates in biennial critical systems review process.
- Responsible for process validation required as a result of changes to validated processes within the PET.
Essential for the role:
- BS in Engineering, or related science
- Minimum 4 years experience in GMP or regulated production environment
- Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, process validation, cleaning validation, technology transfer, change control, applied statistics
- Expertise in at least one of the following disciplines: automation/ controls, aseptic equipment, process/materials, maintenance, validation
- Ability to develop proficiency in all of the following disciplines: automation/ controls, process/materials, maintenance, validation
- Ability to coach and mentor peers
Desirable for the role:
- Advanced technical degree or professional certification
- Proven experience leading a team of technical personnel
- Project management
- Subject Matter Expert in:
- Bulk formulation
- Aseptic processing
- Automated filling
- Automated inspection
- 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 manufacturingenvironment
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
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.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.