Senior Process Engineering Lead - Pharma Ops

AstraZeneca GmbH; Mount Vernon (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

AstraZeneca GmbH is seeking an experienced Process Engineer to provide technical support for formulation areas, lead technology transfers, and optimize manufacturing for oral solid dosage products. The role collaborates across Production, Engineering, Automation, and Quality to improve yield and reliability.

You will drive validation studies, master batch records, and continuous improvements while mentoring junior engineers and supporting regulatory inspections.

Qualifications

• Bachelor’s degree in Science, Chemical Engineering, or related technical discipline.
• Minimum of 10 years’ experience 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.
• Ability to manage multiple major projects with minimum supervision.
• Proven ability to influence others.

Responsibilities

• Provides technical support for formulation areas, investigating and correcting process deviations.
• Identifies projects to reduce cost, improve quality, yield, and material usage.
• Collaborates with production, engineering, automation, and quality to optimize productivity and supply reliability.
• Assists in design and execution of process qualifications and validations for changes.
• Leads technology transfer and implementation from R&D to Mount Vernon site.
• Generates and reviews master batch records; conducts process validation studies.
• Trains and mentors new process engineers and interns.
• Conducts SPC and process capability analyses for TT projects and products.

Skills

Process Engineering

cGMPs

Leadership

Project Management

Troubleshooting

Quality Systems

Education

Bachelor's degree in Science/Engineering

Master’s degree desirable

Tools

IQ/OQ/PQ

Lean Manufacturing

Six Sigma

Job description

AstraZeneca GmbH is seeking an experienced Process Engineer to provide technical support for formulation areas, lead technology transfers, and optimize manufacturing for oral solid dosage products. The role collaborates across Production, Engineering, Automation, and Quality to improve yield and reliability.

You will drive validation studies, master batch records, and continuous improvements while mentoring junior engineers and supporting regulatory inspections.