Quality Control EM/UM and Contamination Specialist

Role Summary

Quality Control EM/UM and Contamination Specialist. Onsite role, Monday through Friday with occasional weekend and off-shift support. Oversees Environmental and Utilities Monitoring and Contamination Control Strategy programs to ensure microbiological integrity, regulatory compliance, and continuous improvement in contamination control.

Responsibilities

• Lead cross-functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices
• Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations
• Partner with Manufacturing, Engineering, Quality Assurance, and Validation teams to assess and mitigate risks related to contamination control of product manufacturing
• Author and review SOPs, protocols, and technical reports related to EM/UM and contamination control
• Provide technical leadership in contamination control, risk assessments, and deviation investigations
• Support regulatory inspections and audits as the SME for EM/UM and contamination control
• Drive continuous improvement initiatives as it relates to contamination control
• Oversee the EM/UM trending and training programs
• Provide training and guidance on aseptic techniques and contamination control principles
• Other duties as assigned

Qualifications

• Bachelor‚Äôs degree in Microbiology, Biology, or related field (Master‚Äôs preferred)
• Minimum 7‚Äì10 years of experience in pharmaceutical microbiology and sterility assurance within a GMP-regulated biologics or pharmaceutical manufacturing environment
• Minimum of 3 years of experience managing EM/UM and Contamination Control programs
• Strong knowledge of aseptic processing, cleanroom classifications/operations, and environmental and utilities monitoring programs
• Experience with regulatory inspections and audit readiness
• Familiarity with regulatory requirements including FDA, EMA, and ICH guidelines
• Proven leadership and team management skills
• Excellent communication, problem-solving, and organizational abilities

Skills

• Experience with biologics drug substance manufacturing (e.g., cell culture, fermentation, purification)
• Experience developing contamination control strategies
• Proficiency in risk assessment tools (e.g., FMEA, HACCP)
• Familiarity with statistical analysis and trending tools