Process Support Engineer

About the Role

Seeking a Process Support Engineer to provide hands-on engineering support for manufacturing operations in a pharmaceutical manufacturing environment. This role will support new product introduction, process development, and improvements to established commercial manufacturing processes. The ideal candidate will be comfortable working directly with manufacturing and technical teams, analyzing processes, developing technical documentation, and identifying opportunities to improve efficiency, quality, and safety. This role requires strong attention to detail and an understanding of GMP-regulated operations and documentation practices.

Key Responsibilities

• Provide engineering support for manufacturing activities, process improvement initiatives, and new product introduction projects.
• Partner with manufacturing, technical operations, quality, and other cross-functional groups to execute project activities.
• Support the evaluation, development, and optimization of manufacturing processes.
• Work hands-on with manufacturing personnel to troubleshoot process-related issues and identify opportunities for improvement.
• Assist with process documentation, technical specifications, reports, and other engineering deliverables.
• Ensure engineering and manufacturing activities are performed in accordance with applicable GMP and Good Documentation Practices (GDP).
• Collect and evaluate process information to support troubleshooting, optimization, and continuous improvement efforts.
• Participate in projects designed to improve manufacturing efficiency, product quality, process reliability, and operational safety.
• Provide technical input during manufacturing activities and help translate process requirements into practical manufacturing solutions.
• Maintain accurate and thorough documentation of engineering activities and project work.
• Continuously develop technical knowledge related to process engineering, pharmaceutical manufacturing, and regulated operations.

Requirements & Tech Stack

• Bachelor’s degree in Engineering, Science, or a closely related technical discipline. Chemical Engineering background preferred.
• Experience supporting manufacturing or process engineering activities.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Ability to work effectively in a fast-paced manufacturing environment.
• Strong written and verbal communication skills.
• Ability to collaborate effectively with cross-functional teams while also working independently.
• Strong attention to detail and commitment to accurate technical documentation.
• Ability to adapt to changing priorities and learn new processes and technologies.
• Process Engineering
• Manufacturing Process Support
• New Product Introduction (NPI)
• Process Optimization
• Troubleshooting & Root-Cause Analysis
• GMP / GDP Documentation
• Technical Reporting
• Process Documentation
• Continuous Improvement
• Cross-Functional Project Support

Qualifications

• Experience within a pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environment is preferred.
• Previous exposure to New Product Introduction (NPI) activities is preferred.
• Experience with process optimization or continuous improvement initiatives is preferred.
• Familiarity with GMP and Good Documentation Practices (GDP) is preferred.
• Experience developing technical reports, specifications, or manufacturing documentation is preferred.