Process Development Engineer - Morgan McKinley

The role involves working on large-scale expansion projects and supporting both small and large molecule manufacturing operations. The position requires close collaboration with cross-functional teams, a strong background in aseptic processing, and expertise in qualification and validation of formulation and filling systems.

• Support the development and characterisation of single-use systems and filling technologies.
• Lead the creation and verification of qualification protocols for single-use systems.
• Support formulation and filling process development, including protocol creation, execution, and reporting.
• Lead cross-functional teams to drive complex projects to completion.
• Perform risk assessments and implement CAPAs for drug product operations.
• Provide technical support for drug product manufacturing and technology transfer activities.
• Investigate and troubleshoot equipment or processing issues using data-driven approaches.
• Participate in deviation resolution and root cause investigations.
• Collaborate with site teams, engineering, and vendors on new equipment impacting validated processes.
• Contribute to validation protocols, quality documentation, and product quality assessments.
• Ensure compliance with regulatory requirements and internal quality standards.

• Bachelor's degree in Science, Engineering, or related discipline with 5+ years of relevant experience, or
• Master's degree with 3+ years of relevant experience, or
• Associate's degree with 10+ years of relevant experience.
• In-depth knowledge of cGMP and aseptic manufacturing practices.
• Strong communication and technical writing skills.
• Experience in developing formulation and filling systems using engineering and scientific principles.

Preferred:

• 10+ years of experience in commercial drug product processing, including sterile processing, tech transfer, and validation.
• Background in protein drug product formulation and filling technologies.
• Experience with peristaltic and time-pressure filling systems.
• Familiarity with protein stability and biochemistry.
• Strong understanding of quality systems and regulatory compliance.