Associate Director Principal Engineer

AstraZeneca•Mount Vernon, IN

About The Position

The Associate Director Principal Engineer provides technical support for process manufacturing, investigates and corrects process-related problems and deviations from standards, and serves as a subject matter expert across multiple processing operations. The position provides technical leadership within the Process Engineering team and may lead technology transfers to and from the site. The role supports pharmaceutical manufacturing of oral solid dosage products, including tablets and capsules. It leads or contributes to technology transfers, product scale-up, process validation, process optimization, and implementation of manufacturing technologies, equipment, and systems. It also develops and maintains manufacturing documentation, supports inspections, and works with Production, Engineering, Automation, and Quality to improve productivity, quality, yield, and supply reliability.

Requirements

Bachelor’s degree in Science, Chemical Engineering, or another related technical discipline.
At least 10 years of experience in pharmaceutical production, process engineering, project engineering, or project management.
Experience in the oral solid dosage pharmaceutical industry.
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.
Demonstrated ability to manage multiple major projects simultaneously with minimal supervision.
Proven ability to influence.

Nice To Haves

Master’s degree and/or PhD.
Experience with IQ/OQ/PQ and Lean Manufacturing.
Six Sigma certification.
Experience with Statistical Process Control and Process Capability Analysis.

Responsibilities

Provide technical support for formulation and process manufacturing areas, including investigating and correcting process, manufacturing, and quality problems and deviations from standards.
Identify and execute projects to reduce product cost and material usage and improve product quality and yield.
Collaborate with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability.
Assist in designing and executing process qualifications and validations for approved changes.
Initiate process manufacturing area change proposals for projects managed by Formulation or Process Engineering.
Author, update, review, and approve area procedures to ensure accurate content and compliance with Good Manufacturing Practices.
Author, review, and approve formulation master batch records.
Serve as a subject matter expert for technical formulation projects during internal audits and regulatory inspections.
Lead technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites to the Mount Vernon site.
Enhance manufacturing systems for existing products as Product Owner, including designing, executing, and evaluating experimental plans to establish process capabilities, specifications, and robustness.
Execute the site Process Analytical Technology (PAT) strategy to monitor and control existing manufacturing processes.
Provide pharmaceutical process support for new and existing oral solid dosage form products and processes, including tablets and capsules.
Train and mentor new Process Engineers and interns.
Develop product and process knowledge across multiple product streams and technologies.
Lead product scale-up activities related to volume increases and product demand.
Manage technology transfer for new solid oral dosage form products transferred to the site, as required.
Design and execute process validation studies supporting commercialization of technology-transfer products.
Identify, recommend, and implement equipment modifications to improve or optimize process performance.
Contribute to equipment User Requirements Specification development and retrofit activities, and participate in equipment Factory Acceptance Tests and Site Acceptance Tests.
Justify processing parameters and conduct scale-up activities.
Introduce new manufacturing processes, technologies, including Process Analytical Technologies, and systems, and define required equipment and facilities.
Transfer and start up new products and processes through plant trial runs or clinical/pivotal stability lots, ensuring robust and efficient implementation.
Conduct statistical process control and process capability analyses for technology-transfer projects and existing products.
Investigate unexpected trends or results and conduct troubleshooting and root-cause analysis related to product quality and financial aspects affected by material or process factors during technology transfer or routine production.
Identify and implement effective industry best practices in technology transfer and pharmaceutical manufacturing to create a competitive advantage for the site.
Conduct activities in accordance with company values, the Code of Ethics, applicable policies and standards, and required training and reporting expectations.
Ensure compliance with corporate policies and directives, site procedures and policies, work instructions, regulatory requirements, and industry practices including cGMPs, GAMP, ITIL, and PMI.
Maintain a safe work environment, follow Safety, Health, and Environment policies and procedures, and report potential unsafe conditions to management.
Support internal, external, and regulatory inspections, including FDA, EMEA, and third-party inspections.
Participate in investigating and resolving product quality problems and execute work in compliance with cGMPs, site policies, work instructions, and SOPs.