Contamination Control Engineer - GMP

Role Summary

Contamination Control Specialist responsible for leading contamination control programs, conducting risk assessments, and ensuring GMP-compliant practices across manufacturing operations. Serves as a subject-matter expert on contamination control, leads investigations and CAPAs, and collaborates with cross-functional teams to protect product quality. Maintains presence on the shop floor to oversee practices and drive continuous improvements in contamination control.

Responsibilities

• Leading as SME for specific subjects as part of the Contamination Control SOP
• Conducting risk assessments related to contamination control
• Overseeing site activities and performance for contamination control systems within scope
• Leading investigations following contamination control failures and proposing corrective and preventive actions (CAPA)
• Collaborating with cross-functional teams to ensure product quality
• Ensuring presence on the shop floor to oversee practices and identify gaps vs SOP for contamination control
• Reviewing data from contamination control monitoring to propose improvements as necessary
• Participating in audits and regulatory inspections, providing expertise on contamination control
• Supporting the preparation of validation Protocols and projects related to area of expertise
• Contributing as an SME to specific CoE/CoP with Global functions; implementing on-site best practices

Qualifications

• Required: Bachelor's degree in Science or Engineering and a minimum of 6 years’ experience in a regulated, cGXP environment; or Master’s degree with a minimum of 3 years’ experience in a regulated, cGXP environment
• Required: Experience in operations in Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation
• Required: Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
• Preferred: Additional experience with GMP-related contamination control practices and regulatory expectations

Skills

• Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with GOP / Quality standards
• In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP) relevant to sterility assurance and microbiological control
• Communication skills to interact with a wide range of functions (shop floor to management) and present complex subjects
• Ability to organize and lead routine investigations with a multi-disciplinary team

Education

• Bachelor's degree in Science or Engineering
• Master's degree (optional) in a related field

Additional Requirements

• Ability to gown and gain entry to controlled, classified areas