Environmental Monitoring Program Lead Consultant

ProPharma Group; New York (NY); On-site; USD 124,000 - 207,000; Full time

Job summary

ProPharma Group seeks an experienced consultant to lead a comprehensive assessment of environmental monitoring and contamination control programs for a three-month engagement in Kansas City. The role involves evaluating procedures, investigations, sampling strategies, cleaning practices, and risk assessments within sterile manufacturing environments.

The consultant will evaluate EM procedures and contamination control measures, perform investigations and trending analyses, assess cleaning

Qualifications

• 10+ years of experience in environmental monitoring and microbiology.
• Expertise in contamination control and cleaning/disinfection practices.
• Knowledge of Annex 1 and sterile manufacturing regulations.
• Experience with EM procedures, investigations, and trending analysis.
• Risk assessment development and implementation skills.

Responsibilities

• Evaluate existing environmental monitoring procedures and contamination control programs.
• Conduct investigations and trending analysis of EM data and findings.
• Assess cleaning and disinfection practices and effectiveness.
• Review sampling strategies and risk assessments for sterile manufacturing.
• Provide recommendations to optimize monitoring and control protocols.

Skills

Environmental monitoring

Contamination control

Trending analysis

Cleaning & disinfection

Risk assessment

Job description

ProPharma Group seeks an experienced consultant to lead a comprehensive assessment of environmental monitoring and contamination control programs for a three-month engagement in Kansas City. The role involves evaluating procedures, investigations, sampling strategies, cleaning practices, and risk assessments within sterile manufacturing environments.

Responsibilities

• Evaluate existing environmental monitoring procedures and contamination control programs
• Conduct investigations and trending analysis of EM data and findings
• Assess cleaning and disinfection practices and effectiveness
• Review sampling strategies and risk assessments for sterile manufacturing
• Provide recommendations to optimize monitoring and control protocols

Requirements

• 10+ years of experience in environmental monitoring and microbiology
• Demonstrated expertise in contamination control and cleaning/disinfection practices
• Knowledge of Annex 1 and sterile manufacturing regulations
• Experience with EM procedures, investigations, and trending analysis
• Risk assessment development and implementation skills