Senior Process Engineer - Contamination Control

Responsibilities:

• Lead the development, implementation, and maintenance of contamination control strategies in line with GMP (Good Manufacturing Practices) requirements.
• Monitor and analyze contamination risks throughout the manufacturing process, ensuring that systems, processes, and procedures mitigate contamination risks effectively.
• Conduct contamination risk assessments (FMEA, HACCP, etc.) and develop action plans to mitigate identified risks.
• Identify opportunities for process improvement, ensuring the continued reduction of contamination risks in the manufacturing environment.
• Collaborate with cross-functional teams to design and implement engineering controls, such as cleanroom configurations, air handling systems, and sterilization protocols.
• Oversee the evaluation and qualification of new equipment, technologies, and systems to ensure they meet contamination control standards.
• Ensure compliance with all relevant regulatory guidelines (FDA, EMA, etc.) and internal procedures related to contamination control.
• Lead the preparation of documentation and reports for regulatory inspections and audits, ensuring readiness for external audits and inspections.
• Support the development and ongoing improvement of SOPs (Standard Operating Procedures) related to contamination control.
• Work closely with the Quality Assurance, Manufacturing, and Validation teams to ensure contamination control is embedded into all stages of the product lifecycle.

Qualifications:

• Bachelor's degree or above in Chemical Engineering, Biotechnology, Biochemical Engineering, or a related field.

• Minimum of 5-7 years of experience in process engineering, contamination control, or a related field within a biopharmaceutical/CDMO environment.

• Knowledge of relevant regulatory guidelines (FDA, EMA, ICH, etc.) and contamination control standards (ISO, EU GMP, etc.).

• Ability to develop and implement contamination control protocols and SOPs.