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 outstanding skills with those of people from all over the globe.

The Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets, capsules, powders and liquids to over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.

The Senior Process Engineer - Formulation will provide technical support for formulation, including investigation and correction of process-related problems and deviations from standards. Serves as a Subject Matter Expert for multiple processing operations and provides technical leadership within the Process Engineering team. May lead Technology Transfers to and from site.

What you’ll do:

• Provides technical support for Formulation areas, including investigation and correction of process-related problems and deviations from standards and responsible for identifying and executing projects to reduce product cost, improve product quality, improve yield, and reduce material usage.
• Collaborates with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability and designs and executes process qualifications and validations for approved changes.
• Initiates Formulation area change proposals as required for projects led by the Manufacturing Technology group. Authors, updates, reviews, and approves area procedures to ensure correct content and compliance with Good Manufacturing Practices. Authors and reviews Formulation master batch records.
• Serves as a subject matter expert (SME) for technical projects affecting Formulation during internal audits and regulatory inspections and leads technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, to the Mount Vernon site.
• Responsible for providing pharmaceutical process support to new and existing oral solid dose form (tablet and capsule) products/processes.
• Trains and mentors new Process Engineers and interns. Develops Product/Process knowledge in multiple product steams and technologies. Leads product scale up activities related to volume increases and/or product demand.
• Assists Technology Transfer for new solid oral dosage form (tablet and capsule) products being transferred to the site as required and Identifies, recommends, and implements equipment modifications to ensure improved/optimized process performance.
• Assists the transfer and startup of new products/processes through plant trial runs and or clinical/pivotal stability lots, guaranteeing implementation of a robust and efficient process.
• Provides technical support, including investigation and correction of manufacturing technical/quality issues that could potentially lead to a disruption in product supply.
• Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results related to product quality and financial aspects due to material and/or process related factors during the execution of routine production.

Essential for the role:

Required:

• Bachelor of Science degree required, preferably in Science, Chemical Engineering, or other related technical subject area and minimum of 5 years experience (or Master’s plus 3 years) in pharmaceutical production, process engineering, project engineering, or project management. Experience in the OSD pharmaceutical industry preferred.
• Strong understanding of cGMPs; demonstrated leadership, management, and technical capabilities.
• Excellent verbal, written, and interpersonal communication skills are critical.
• Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives.
• Demonstrated ability to organize and implement projects that improve the operational effectiveness of process manufacturing.

Preferred:

• Master’s degree is desirable.
• Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable. Six Sigma certification is preferred.
• Experience with Statistical Process Control, Process Capability Analysis, and Risk Assessment/Management.

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 ambitious - 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, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Next Steps – Apply today!

To be considered for this great 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 an excellent fit, please share this posting with them.

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.