Senior Engineer - Manufacturing/Commissioning & Qualification (C&Q)

Responsibilities

• Lead process optimization, troubleshooting, and continuous improvement initiatives for manufacturing operations
• Develop and implement engineering solutions for complex technical and operational challenges
• Execute Commissioning & Qualification (C&Q) strategies, including FAT, SAT, and field verification
• Author, review, and execute IQ, OQ, and PQ protocols
• Manage engineering projects from planning through implementation, including scope, schedule, and budget
• Lead risk assessments and manage Change Control activities affecting validated systems
• Investigate deviations and implement corrective and preventive actions (CAPA)
• Partner with cross-functional teams including Manufacturing, Quality, and Supply Chain

Requirements

• Doctorate degree OR
• Master's degree with 2+ years of Engineering experience OR
• Bachelor's degree in Engineering with 4+ years of Engineering experience
• Strong understanding of engineering principles and manufacturing processes
• Knowledge of GMP, GLP, and validation requirements
• Excellent technical writing and documentation abilities

Preferred Qualifications

• Experience in biotechnology, pharmaceutical, or medical device manufacturing
• Experience with packaging equipment and packaging process engineering
• Experience leading Commissioning & Qualification (C&Q) activities
• Knowledge of risk assessment methodologies and validation lifecycle practices
• Familiarity with electronic quality and document management systems

Benefits

• 6-month contract with possible extension
• Administrative Shift