AstraZeneca Pharmaceuticals LP Formulation Senior Process Engineer - Mount Vernon, IN - Global Operations in Mount Vernon, Indiana
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 Formulation Senior Process Engineer on the Process Engineering Team (PET) 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.
You will be 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.
Main Duties and 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.
Designs and executes process qualifications and validations for approved changes.
Initiates Formulation area change proposals as required for projects managed 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.
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 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.
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.
Assists in justifying processing parameters and assists scale-up activities.
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.
Bachelor of Science degree required, preferably in Science, Chemical Engineering, or other related technical discipline.
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.
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!
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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.