Contamination Control - HACCP Expert

The Contamination Control Risk Management Specialist is responsible for developing, implementing, maintaining, and continuously improving contamination control risk management programs across pharmaceutical, biotechnology, aseptic manufacturing, and medical device operations. The role focuses on application of Hazard Analysis and Critical Control Points (HACCP), contamination control strategies (CCS), particulate matter risk assessments, and Annex 1 compliance to ensure product quality, patient safety, and regulatory compliance.

This position serves as the subject matter expert for contamination hazards, particulate contamination risks, aseptic process risks, and contamination control effectiveness throughout the product lifecycle.

Key Responsibilities

Contamination Control Risk Management

• Lead contamination control risk assessments utilizing HACCP, Risk Analysis, PFMEA, and Hazard Analysis methodologies.
• Develop and maintain site-wide Contamination Control Strategies (CCS) in alignment with EU GMP Annex 1 requirements.
• Identify and evaluate contamination hazards including:
• Viable contamination
• Non-viable particulate contamination
• Cross-contamination
• Personnel contamination
• Utility-related contamination
• Environmental contamination
• Raw material contamination
• Establish risk-based contamination control measures and monitoring strategies.
• Facilitate multidisciplinary risk assessment workshops.

HACCP Program Management

• Develop and maintain HACCP plans for aseptic and non-aseptic manufacturing processes.
• Conduct hazard identification and critical control point (CCP) determination.
• Define:
• Critical limits
• Monitoring requirements
• Corrective actions
• Verification activities
• Ensure HACCP documentation remains current and inspection-ready.
• Support regulatory inspections and audits related to contamination control.

Particulate Matter Risk Management

• Lead particulate contamination risk assessments across facilities, equipment, processes, and products.
• Evaluate particulate generation sources including:
• Personnel activities
• Equipment wear
• Packaging materials
• Single-use systems
• HVAC systems
• Cleaning activities
• Manufacturing processes
• Perform risk evaluations for:
• Visible particles
• Sub-visible particles
• Environmental particulate contamination
• Develop mitigation strategies to reduce particulate contamination risks.
• Support investigations involving particulate excursions and contamination events.

Environmental Monitoring & Trending

• Analyze environmental monitoring data and contamination trends.
• Conduct contamination risk reviews based on:
• Non-viable particulate monitoring
• Viable environmental monitoring
• Utility monitoring
• Cleanroom performance data
• Establish action and alert levels using risk-based approaches.
• Identify emerging contamination risks and recommend preventive actions.

Quality Risk Management Integration

• Integrate contamination control risk assessments with:
• PFMEA
• Hazard Analysis
• Process Risk Assessments
• Change Controls
• Deviations
• CAPA Programs
• Ensure contamination risks are reflected within overall quality risk management processes.
• Support lifecycle contamination risk management activities.

Investigations & Remediation

• Lead root cause investigations for contamination events.
• Conduct impact assessments for:
• Environmental excursions
• Sterility failures
• Microbial contamination
• Particulate contamination findings
• Develop and track CAPAs related to contamination control deficiencies.
• Verify effectiveness of implemented corrective actions.

Regulatory Compliance

• Ensure compliance with:
• EU GMP Annex 1
• ICH Q9 Quality Risk Management
• ISO 14971 (where applicable)
• PDA Technical Reports
• USP <788>, <789>, and applicable particulate requirements
• FDA aseptic processing guidance
• ISO 14644 cleanroom standards
• Support inspections by FDA, EMA, MHRA, and notified bodies.

Required Qualifications

Education

• Bachelor's degree in:
• Microbiology
• Pharmaceutical Sciences
• Biotechnology
• Engineering
• Quality Assurance
• Related scientific discipline

Experience

• 5+ years of experience in contamination control, quality risk management, microbiology, aseptic processing, or quality assurance.
• Experience conducting HACCP risk assessments.
• Experience developing contamination control strategies.
• Experience investigating contamination and particulate matter events.

Technical Knowledge

Strong understanding of:

• HACCP methodology
• Contamination Control Strategy (CCS)
• EU GMP Annex 1
• Risk Management Principles
• PFMEA
• Hazard Analysis
• Cleanroom Operations
• Environmental Monitoring
• Aseptic Processing
• Particulate Matter Control
• Root Cause Analysis
• CAPA Systems

Pay: $30.00 - $45.00 per hour

Work Location: Remote