QC Microbiologist II

Responsibilities

• Perform routine environmental monitoring of classified clean rooms
• Monitor classified clean rooms during manufacturing operations, including gown qualification
• Sample and test Water for Injection, USP Purified Water, and Clean Steam systems
• Document plate reads for all environmental and utility testing with minimal supervision
• Write and execute protocols, experiments, and SOPs
• Review peer work and manage SOP document changes
• Assist senior staff with investigations, reports, and complex protocols
• Perform visual inspection of media fill vials and plates
• Conduct general laboratory maintenance and housekeeping
• Train staff in routine processes

Requirements

• High School Diploma required
• 5-7 years of experience in a cGMP environment (Note: 2 years of experience may be replaced by an Associate's/Non-Scientific Bachelor's degree; 3 years may be replaced by a BS/BA in Microbiology or a related scientific field)
• Ability to gown for an ISO-5 environment
• Ability to work varied hours as required by the production schedule (Shift: Mon-Fri 3:30 PM - 12 AM)
• Physical ability to wear laboratory protective equipment, including goggles, face shields, and gloves
• Ability to stand or sit for prolonged periods and occasionally lift up to 50 pounds

Preferred Qualifications

• BS/BA degree in Microbiology or a related scientific field

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to building the bridge between life-changing therapies and patients. We invest in people who drive progress and create a better tomorrow through a culture of purposeful work and intentional learning.