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

What you'll do:

The Aseptic Control Senior Specialist is responsible for execution of the environmental monitoring and aseptic control activities in accordance with the site operating strategy and the aseptic strategy as developed by the Director of Microbiology. 

The Aseptic Control Senior Specialist must be willing to work a flexible schedule that allows oversight of all production shifts.

• Develop ACT cleanroom classification and Environmental Monitoring Performance Qualification protocol and final summary reports as well as maintenance of related document updates
• Lead ACT risk assessments for EM trends, abnormal events relating to aseptic quality and environmental control.
• Lead ACT critical process evaluations and sampling location selection assessments
• Lead and/or support EM / Aseptic Control deviation reports
• Complete EM / Aseptic Control CAPAs
• Complete Change Controls associated with guidance updates, site process improvements and inspection observations.
• Support ACT program with justifications/rationalizations

• Work on the plant floor to identify and correct microbial deficiencies
• Lead process improvement activities and teams to meet strategic goals.

Essential for the role:

• Bachelor of Science in Biology, Microbiology, Engineering, Pharmacy, related Science or business.
• Minimum 5 years’ experience in production, aseptic or quality control environment.
• Experience writing investigations and has knowledge of key investigational methods
• Experience quality risk management assessments

Desirable for the role:

• Experience working in a LEAN manufacturing environment
• Working knowledge of LDMS or AZDocs, Microsoft applications, SAP, Trackwise
• Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, change control.
• Knowledge or previous experience in managing technical programs/projects
• Strong mechanical, troubleshooting and problem-solving abilities.
• Ability to direct and participate in cross-functional teams.
• Project management skills.

Why AstraZeneca?

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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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.