PET Formulation Senior Process Engineer

AstraZeneca•Mount Vernon, IN

2d•Onsite

About The Position

The AstraZeneca Mt. Vernon site, established in 1972, is a key facility for delivering innovative oral solid medicines. This complex site, the largest AZ production facility in the US with over 700 employees, formulates and packs OSD tablets and capsules for over 60 markets. Located in Indiana, the Mt. Vernon site is collaborative and inclusive, with employee resource groups promoting diversity, inclusion, and professional development. The site offers various perks including an on-site fitness center, walking trail, basketball court, tuition reimbursement, and a dining center. As a PET Formulation Senior Process Engineer, you will provide technical support for formulation processes, investigate and resolve process-related problems and deviations, and serve as a Subject Matter Expert. You will also lead Technology Transfers and contribute to the optimization of product cost, quality, and yield.

Requirements

Bachelor of Science degree required, preferably in Science, Chemical Engineering, or other related technical discipline.
Minimum of 4 years experience (or Master’s plus 1 year) in pharmaceutical production, process engineering, project engineering, or project management.
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.

Nice To Haves

Master’s degree is highly desirable.
Experience in continuous manufacturing.
Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable.
Six Sigma certification is preferred.
Experience in the OSD pharmaceutical industry preferred.
Experience with Statistical Process Control, Process Capability Analysis, and Risk Assessment/Management.
Experience with continuous direct compression and/or spray drying.

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 streams 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.
Conducts statistical process control and process capability analysis for 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 routine production.