PET Formulation - Process Engineer

AstraZeneca•Mount Vernon, IN

About The Position

The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. Join us as a Formulation Process Engineer in our Operations department, where you will be responsible for providing technical support for process manufacturing, including investigation and correction of process-related problems and deviations from standards. This is an exciting opportunity to learn more working at the cutting-edge and embrace constant challenges, which for us are intellectually stimulating opportunities to learn more. The PET Formulation - Process Engineer is responsible for providing technical support for process manufacturing, including investigation and correction of process-related problems and deviations from standards.

Requirements

Bachelor’s degree required, preferably in Science, Chemical Engineering, or other related technical discipline.
Strong understanding of cGMPs.
Demonstrated leadership, management, and technical capabilities.
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.
0-3 years of relevant experience.

Nice To Haves

Master’s degree or 2 years’ relevant experience.
Experience with IQ/OQ/PQ and Lean Manufacturing.
Six Sigma certification.
Excellent verbal, written, and interpersonal communication skills.

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 and cleaning qualifications and validations.
Initiates Formulation area change proposals as required for projects managed by the Process Engineering group.
Updates, reviews, and approves area procedures to ensure correct content and compliance with Good Manufacturing Practices.
Authors, reviews, and approves Formulation master batch records.
Assists as a subject matter expert for technical projects affecting Formulation during internal audits and regulatory inspections.
Supports technical transfer and implementation of new technologies, equipment, and processes from R&D and other sites, to the Mount Vernon site.
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.
Participates in the investigation and resolution of product quality problems.
Executes work in compliance with cGMPs, site policies, work instructions, and SOPs.