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Sr Process Engineer / Principal Process Engineer – Formulation - Mt Vernon, IN - Global Operations

Location Mount Vernon, Indiana, United States Job ID R-073477 Date posted 02/06/2020

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Sr Process Engineer / Principal Process Engineer in Mt. Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.

The Sr Process Engineer / Principal Process Engineer is responsible providing technical support for process manufacturing, 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 and manage Technology Transfers to and from the site.

This position could be filled as a Sr Process Engineer or a Principal Process Engineer.

Job Responsibilities:

  • Provides technical support for formulation areas, including investigation and correction of process related problems and deviations from standards. 
  • 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. 
  • Assists in designs and execution of process qualifications and validations for approved changes. 
  • Initiates process manufacturing area change proposals as required for projects managed by the Formulation or Process Engineering group. 
  • Authors, updates, reviews, and approves area procedures to ensure correct content and compliance with Good Manufacturing Practices. 
  • Authors, reviews, and approves formulation master batch records. 
  • Serves as a subject matter expert 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. 
  • Enhances quality and effectiveness of manufacturing systems related to existing products as the Product Owner. This includes the design, execution, and evaluation of experimental plans to ascertain the required process capabilities, specifications, and robustness. 
  • Executes site PAT strategy to monitor and control existing manufacturing processes. 
  • 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 streams and technologies. 
  • Leads product scale up activities related to volume increases and/or product demand. 
  • Responsible for Technology Transfer for new solid oral dosage form (tablet and capsule) products being transferred to the site as required. 
  • Designs and executes Process Validation Studies supporting the commercialization of the TT products. 
  • Identifies, recommends, and implements equipment modifications to ensure improved/optimized process performance. 
  • Contributes to Equipment URS development and retrofit. Participates in Equipment FATs, SATs, etc. 
  • Justifies processing parameters and conducts scale-up activities. 
  • Introduces new manufacturing processes, technologies (including Process Analytical Technologies), and systems including the definition of equipment and facilities needed. 
  • Executes 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 process manufacturing areas, including investigation and correction of manufacturing technical/quality issues that could potentially lead to a disruption in product supply. 
  • Collaborates with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability. 
  • Conducts statistical process control and process capability analyses for TT projects and existing products. 
  • 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 TT or routine production. 
  • Identifies best practices in industry related to technology transfers and pharmaceutical manufacturing technologies; implements effective best practices to create a competitive advantage for the site.

Qualifications - Principal Process Engineer:

Education:

  • Bachelor’s degree required, preferably in Science, Chemical Engineering, or other related technical discipline.

Required:

  • Minimum of 10 years of experience in pharmaceutical production, process engineering, project engineering, or project management.  Experience in the OSD pharmaceutical industry required.
  • Strong understanding of cGMPs; demonstrated leadership, management, and technical capabilities.
  • Thorough knowledge of product and process development, manufacturing scale-up, continuous process improvement, and troubleshooting tools and analysis.
  • Excellent verbal, written, and interpersonal communication skills are essential.
  • Must have demonstrated ability to effectively manage multiple major projects at the same time with minimum supervision.
  • Must have a proven ability to influence and work with people at different levels and across different departments within the organization.

Desirable:

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

Qualifications - Sr Process Engineer

Education:

  • Bachelor of Science degree required, preferably in Science, Chemical Engineering, or other related technical discipline.

Required:

  • 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 essential.
  • 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.

Desirable:

  • Master’s degree is highly 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.

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 authorisation and employment eligibility verification requirements.

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