Contamination Control Manager

The Contamination Control Manager prevents contamination risks to OTC drug and cosmetic products through hygienic design, cleaning and sanitization effectiveness, contamination investigations, and risk-based manufacturing controls. The Contamination Control Manager will manage processes and work cross-functionally with stakeholders and operations teams.

Contamination Control Manager Responsibilities:

• Lead investigations of particulate, foreign material, plant debris, and microbiological contamination events
• Identify contamination pathways and drive sustainable CAPA
• Perform risk assessments (FMEA/HACCP) on manufacturing processes, equipment, suppliers, cleaning failures, and facility changes
• Recommend procedural and supplier corrective actions
• Perform risk assessments (FMEA/HACCP) on manufacturing processes, equipment, suppliers, cleaning failures, and facility changes
• Recommend engineering, procedural, and supplier corrective actions
• Establish site cleanliness standards, performance metrics, and conduct routine audits of operations
• Assess new and existing equipment and facility design for contamination risks
• Review pipe velocities, drainability, dead legs, cleanability, and CIP/COP effectiveness
• Evaluate cleaning and sanitization procedures for effectiveness and GMP compliance
• Review cleaning validation/verification strategies, swab locations, acceptance criteria, and inspection methods
• Assess contamination risks from raw materials, packaging, components, and contract manufacturers
• Support supplier audits and corrective action programs
• Influence manufacturing, maintenance, engineering, quality, sanitation, and supplier partners to prioritize contamination control and hygienic design actions
• Provide subject matter expertise and practical recommendations that guide decision-making, risk reduction, and sustainable corrective actions
• Build alignment across teams by clearly communicating risks, connecting technical findings to business and compliance impacts, and driving accountability for follow-through
• Lead cross-functional problem-solving efforts when contamination, cleaning effectiveness, or facility/equipment design concerns require coordinated action

Contamination Control Manager Requirements:

• Bachelor's degree required in one of the following technical fields (i.e biology, chemistry, toxicology, pharma, food science)
• Minimum ten (10) years of experience in a manufacturing company (preferably FDA-regulated)
• OTC drug, cosmetic, pharmaceutical, food, or medical device experience
• Direct contamination investigation experience
• Hygienic equipment design (Preferred)
• Supplier quality (Preferred)
• FDA inspection (Preferred)