22 Aug, 2023

Senior Formulation Process Engineer

  • AstraZeneca
  • Mount Vernon, IA, USA
Engineer Biochemicals / Pharmaceuticals

Job Description

Senior Formulation Process Engineer

Would you like to work in a fast-paced team environment in a company that follows science and turns ideas into life-changing medicines? Are you searching for career growth and development with competitive salaries and benefits? If so, this position would be a phenomenal fit for you!

We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people’s lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalization, and sustainable practices.

AstraZeneca is at an exciting time of new products and launches. We get to work with innovative and scientific products on our leading-edge end-to-end supply chain, using the latest technologies and modern facilities.

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 for 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 Formulation Process Engineer is responsible for providing 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.
  • Responsible for identifying and carrying out projects to reduce product cost, improve product quality, improve yield, and reduce material usage.
  • Designs and implements process qualifications and validations for approved changes.
  • Initiates Formulation area change proposals as required for projects managed by the Manufacturing Technology group.
  • Excellent verbal, written, and interpersonal communication skills are essential.
  • 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.
  • Leads technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, to the Mount Vernon site.
  • Trains and mentors new Process Engineers and interns.
  • 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 for Formulation areas, including investigation and correction of manufacturing technical/quality issues that could potentially lead to a disruption in product supply.
  • Conducts statistical process control and process capability analysis for existing products.

Minimum Qualifications:

  • Bachelor’s degree in Science, Chemical Engineering, or other related technical field.
  • Minimum of 4 years’ experience in pharmaceutical production, process engineering, project engineering, or project management.

Preferred Qualifications:

  • Master’s degree or PHD and 1 or more years of experience in pharmaceutical production, process engineering, project engineering, or project management.
  • Experience with IQ/OQ/PQ and Lean Manufacturing is desirable.
  • Six Sigma certification is a plus.
  • Experience with Statistical Process Control, Process Capability Analysis, and Risk Assessment/Management.
  • Experience in the OSD pharmaceutical industry.
  • Strong understanding of cGMPs; demonstrated leadership, management, and technical capabilities.
  • 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.

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. 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.

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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