Associate Director Principal Engineer

The Associate Director Principal 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.

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.

Accountabilities

▪ Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.

▪ Ensures compliance with AZ Corporate Policies and Directives, site Standard Operating Procedures, site policies, work instructions, regulatory requirements, and industry best practice (cGMPs, GAMP, ITIL, PMI).

▪ Maintains a safe work environment and performs work in accordance with site, Safety, Health, and Environment (SHE) policies and procedures.

▪ Immediately report potential unsafe conditions to management.

▪ Supports internal, external, and regulatory inspections including FDA, EMEA, and third party inspections.

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