PET Formulation Senior Process Engineer

AstraZeneca; Mount Vernon (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

On-site fitness center

Walking trail

Lunch & learns

Tuition reimbursement

Lifelong learning opportunities

Dining center with hot meals

Job summary

AstraZeneca Mount Vernon site is seeking a Senior PET Formulation Process Engineer to provide technical support for formulation, investigate deviations, and lead technology transfers within the Mount Vernon site. You will contribute to process improvements, scale-up activities, and collaboration across Production, Engineering, and Quality to enhance yield and product quality.

The role requires a BS in science/engineering, 4+ years in pharma, and strong cGMP knowledge.

Qualifications

• BS degree in science, chemical engineering or related technical discipline.
• 4+ years of pharma production, process engineering, project engineering, or project management.
• Strong understanding of cGMPs; demonstrated leadership and technical capabilities.
• Excellent verbal and written communication skills.

Responsibilities

• Provides technical support for Formulation areas, including investigation of process problems and deviations.
• Identifies and executes projects to reduce cost, improve quality, yield, and material usage.
• Collaborates with Production, Engineering, Automation, and Quality to optimize productivity and supply reliability.
• Designs and validates process qualifications and changes.
• Leads technology transfer and implementation of new tech, equipment, and processes.
• Trains and mentors new engineers and interns.

Skills

Leadership

Project management

Process engineering

cGMP knowledge

Verbal communication

Written communication

Team collaboration

Education

B.S. in Science/Engineering

Job description

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. The Mt. Vernon site is both collaborative and Inclusive. We have several employee resource groups (ERGs) onsite that are aimed at promoting, celebrating, and educating employees about diversity, inclusion, philanthropy, networking, etc. Each of these groups provide employees with opportunities for interactive and engaging events and initiatives which enhance professional development and provide opportunities to engage with likeminded co-workers.

It is important to us that each employee feels welcome to bring their whole self to work every day. Here is a sneak peek of “perks” the MTV site offers: on-site fitness center with access to a personal trainer, on-site walking trail, walking desk, on-site basketball court, ping pong, massage chair, lunch & learns, sustainable & ergonomic office working environment, tuition reimbursement, training/ lifelong learning opportunities, book club, dining center with hot meals, snack market, free coffee and hot tea, climate controlled work environment.

Are you ready to break new ground and leave a collective legacy? As a PET Formulation Senior Process Engineer, you will provide technical support for formulation, investigating and correcting process-related problems and deviations from standards. You will serve as a Subject Matter Expert for multiple processing operations and provide technical leadership within the Process Engineering team. You may also lead Technology Transfers to and from the site.

Accountabilities

• 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.
• Collaborates with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability.
• 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.

Essential Skills/Experience

• 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.

Desirable Skills/Experience

• 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.

At AstraZeneca, we are at an exciting time of new products and launches. We work with innovative scientific products on our leading-edge end-to-end supply chain using the latest technologies. Our dynamic environment fosters a positive space where ideas are welcomed. We thrive on challenges, continuously learning while proactively taking on more. Our patient focus drives us to deliver life-changing medicines.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.