Aseptic Process Expert

Location: Indiana
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El Masnoutime type:
Full time posted on:
Posted Todayjob requisition :
R25 600"Expect to grow", personally and professionally:
At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
** Your Role:
** As an Aseptic Process Expert, you will play a key role in ensuring the highest standards of sterility, quality, and operational excellence across our manufacturing processes. You will act as a technical reference for aseptic practices, driving continuous improvement and supporting cross-functional teams to maintain robust and compliant operations. In this role, you will:

• Lead and actively participate in cross-functional aseptic governance, providing technical expertise and driving continuous improvement of aseptic behaviors across manufacturing operations.

• Identify and implement process optimization opportunities to enhance operational excellence, product quality, and compliance with global standards.
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* Your Profile:

**** Key Responsibilities*
* • Serve as the primary technical point of contact for manufacturing operations, providing operational and strategic support to ensure safe, timely, and compliant batch execution.  
• Strengthen aseptic culture by developing technical competencies and guiding teams in unplanned or challenging situations.  
• Foster strong collaboration between Manufacturing, Quality, and Maintenance to maintain aseptic integrity and operational reliability.  
• Lead the site’s Aseptic Process Simulation (APS) strategy, including the design, planning, execution, and documentation of the Annual APS Program in alignment with GMP and regulatory expectations.  
• Author and approve APS rationales, protocols, and reports, ensuring data integrity and technical robustness.  
• Coordinate with QA to ensure proper monitoring of aseptic behaviors during APS execution across shifts.  
• Lead and support investigations related to aseptic processes, ensuring timely root cause analysis and effective CAPA implementation, while monitoring CAPA effectiveness through GMP systems.  
• Collaborate with global and local Quality teams to share learnings and ensure alignment with best aseptic practices.
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* Your Benefits:

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* Working Hours:

** Flexible schedule, with start time between 7:30 and 9:30 a.m. and end time between 4:00 and 6:00 p.m.
** Medical Insurance
**** Life and Accident Insurance
**** Subsidized Canteen
**** Pension Plan
**** Remote Work:
** One day week Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof.

This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.### Our purpose drives us to be the strongest team Application Submission & Screening:
Share your qualifications and enthusiasm through our application process. We review each submission to identify candidates whose skills best match the role.
Initial Interview:
We’ll explore your background, aspirations, and how you could contribute to our mission and culture.
On-Site Interview:
If possible, we invite you to meet us in person, connect with future colleagues, and get a feel for our workspace.
Offer Stage:
Congrats! If selected, you'll receive a detailed offer including compensation, benefits, and the exciting opportunities ahead.
Onboarding:
After you accept, we’ll guide you through a smooth, tailored onboarding experience to help you settle into your new role.
Feedback & Improvement:
Your feedback helps us continuously improve and enhance the candidate experience for others.
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