Process Engineer II
Seeking an experienced Process Engineer II to support manufacturing operations in a GMP-regulated environment. This role is responsible for providing technical support to automated production lines, driving process improvements, troubleshooting manufacturing issues, leading investigations, and supporting validation and equipment qualification activities.
Key Responsibilities
• Provide day-to-day technical support for manufacturing operations
• Lead deviation investigations, root cause analysis, and CAPA implementation
• Author and revise technical documentation, protocols, and risk assessments
• Support process validation, equipment qualification, and technology transfer activities
• Drive process improvements through data analysis and trending
• Partner with Manufacturing, Quality, Engineering, QC, and Supply Chain teams
• Support change control activities and regulatory inspection readiness
• Ensure compliance with cGMP, FDA, ISO, and quality system requirements
Qualifications
• Bachelor's degree in Engineering, Chemistry, or related technical field
• Experience in pharmaceutical, medical device, sterile injectable, or radiopharmaceutical manufacturing
• Strong knowledge of cGMPs, aseptic processing, cleanroom operations, and quality systems
• Experience with deviation investigations, CAPA, process validation, and equipment qualification
• Excellent technical writing, problem-solving, and communication skills
• Experience with electronic quality systems such as TrackWise or similar platforms
This is an excellent opportunity to join a growing team supporting cutting-edge radiopharmaceutical manufacturing and make a direct impact on product quality, process performance, and patient care
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