Senior Process Facilitator – 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
What you'll do:
The Senior Process Facilitator is a leader for the Process Operation (Filling). In this capacity, the Process Facilitator leads the Process / Package Operation to produce high quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with other Process Facilitators), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards.
- Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with the PET Plan or Rhythm Wheel
- Responsible for all PET activity to include coordination of support staff, scheduling and improvement.
- Promotes the use of safe work practices during all aspects of production and ensures all external and AstraZeneca SHE standards are met daily.
- Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partners with PET Coach to develop training plans and assist in providing resources for training.
- Ensures that cGMP’s are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations.
- Promotes a positive work environment by effectively administering AstraZeneca Human Resources policies and procedures including Performance Management and by communicating information to employees and responding to their concerns.
- Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
- Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
- Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
- Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators and recognition and rewarding high performance.
- Collaborates with OE Engineers & PET Engineers to optimize process performance.
- Participates in the design, selection, installation and qualification of new equipment, facilities, and processes
Essential for the role:
- Bachelor of Science in Engineering, Pharmacy, related Science or business.
- 5+ years of experience in GMP or regulated production environment
- Minimum of 1-3 years previous supervisory experience.
- Knowledge of FDA cGMP’s.
- Strong communication and leadership skills.
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 formulation, filling, packaging, validation, technology transfer, change control.
- Knowledge or previous experience in managing technical programs/projects
- Strong mechanical, electrical, troubleshooting and problem-solving abilities.
- Ability to direct and participate in cross-functional teams.
- Project management skills.
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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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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.