Principal Process Engineer – PET - (Mount Vernon, IN)

  • Company: AstraZeneca
  • Location: Mount Vernon, Indiana
  • Posted: December 16, 2017
  • Reference ID: R-016985
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 Principal Process Engineer in Mount 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.
Main Duties and Responsibilities
The 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.
Job Responsibilities
  • You will provide technical support for formulation areas, including investigation and correction of process-related problems and deviations from standards.
  • You will be responsible for identifying and executing projects to reduce product cost, improving product quality, improving yield, and reducing material usage.
  • You will collaborate with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability.
  • You will assist in design and execution of process qualifications and validations for approved changes
  • You will initiate process manufacturing area change proposals as required for projects managed by the Formulation or Process Engineering group.
  • You will author, update, review, and approve area procedures to ensure correct content and compliance with Good Manufacturing Practices.
  • You will author, review and approve formulation master batch records.
  • You will serve as a subject matter expert for technical projects affecting formulation during internal audits and regulatory inspections.
  • You will lead technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, to the Mount Vernon site.
  • You will enhance 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.
  • You will execute site PAT strategy to monitor and control existing manufacturing processes.
  • You will be responsible for providing pharmaceutical process support to new and existing oral solid dose form (tablet and capsule) products/processes.
  • You will train and mentor new Process Engineers and interns.
  • You will develop Product/Process knowledge in multiple product streams and technologies.
  • You will lead product scale up activities related to volume increases and/or product demand.
  • You will be responsible for Technology Transfer for new solid oral dosage form (tablet and capsule) products being transferred to the site as required.
  • You will design and execute Process Validation Studies supporting the commercialization of the TT products.
  • You will identify, recommend and implement equipment modifications to ensure improved/optimized process performance.
  • You will contributes to Equipment URS development and retrofit. You will participate in Equipment FATs, SATs, etc.
  • You will justify processing parameters and conducts scale-up activities.
  • You will introduce new manufacturing processes, technologies (including Process Analytical Technologies), and systems including the definition of equipment and facilities needed.
  • You will execute 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.
  • You will provide 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.
  • You will collaborate with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability.
  • You will conduct statistical process control and process capability analyses for TT projects and existing products.
  • You will investigate and conduct 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.
  • You will identify best practices in industry related to technology transfers and pharmaceutical manufacturing technologies; implements effective best practices to create a competitive advantage for the site.
The incumbent is not necessarily performing all the Major Responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
Typical Accountabilities
  • You will support internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections to provide information for Formulation and/or Technical Services.
  • You will lead, as a Technical SME, any Pre-Approval Inspections during Technology Transfer activities.
  • You will coordinate and participate in the investigation and resolution of product quality problems.
  • You will execute work in compliance with GMPs, site policies, work instructions, and SOPs.
Essential Requirements
  • Bachelor's degree required, preferably in Science, Chemical Engineering, or other related technical discipline.
  • 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 Requirements
  • 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.
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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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