Senior Process Engineer - Inspection

Responsibilities:

• Lead the development, optimization, and validation of inspection processes and systems, ensuring compliance with GMP regulations.
• Investigate and resolve process deviations, non-conformances, and inspection failures. Perform root cause analysis and implement corrective actions to prevent recurrence.
• Utilize Six Sigma, FMEA, and other methodologies to identify process inefficiencies and develop action plans for continuous improvement.
• Evaluate, implement, and optimize automated inspection systems, vision systems, and other technologies to enhance the efficiency, accuracy, and reliability of product inspection.
• Oversee the qualification and validation of new inspection equipment and systems to ensure they meet regulatory standards and operational requirements.
• Ensure that inspection processes meet regulatory requirements, including FDA, EMA, ISO, and other applicable standards.
• Develop and maintain Standard Operating Procedures (SOPs), work instructions, and validation protocols. 
• Prepare for and support regulatory inspections and audits by providing necessary documentation and process information.

Qualifications:

• Bachelor’s degree or higher in Chemical Engineering, Biotechnology, Mechanical Engineering, or a related field.
• 5-7 years of experience in process engineering, with a focus on inspection processes, in a biopharmaceutical or CDMO environment.
• Familiarity with risk management techniques (e.g., FMEA, RCA) and continuous improvement methodologies (e.g., Lean, Six Sigma).
• Strong understanding of regulatory guidelines such as FDA, EMA, ISO, and GMP requirements.
• Excellent documentation skills with experience in writing SOPs, validation protocols, and compliance reports.