Job Title: Sterility Assurance Lead

Location: CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603

Job Overview

The Sterility Assurance Lead is accountable for ensuring that aseptic processing systems and sterility assurance controls are designed, implemented, monitored, and maintained in a validated state of control, in alignment with FDA Aseptic Processing Guidance, EU GMP Annex 1, and applicable ICH guidelines. This role owns the Contamination Control Strategy (CCS) and provides site-level technical leadership to ensure contamination risks are systematically identified, scientifically assessed, and effectively mitigated throughout the facility and product lifecycle. The Sterility Assurance Lead serves as the primary subject matter expert during regulatory inspections and drives inspection-ready, data-supported decision making.

Key Responsibilities
• Own, implement, and continuously improve the site Contamination Control Strategy (CCS), ensuring it is comprehensive, risk-based, and maintained throughout the lifecycle of facilities, utilities, equipment, processes, and products.
• Ensure aseptic processing controls are scientifically justified, data-driven, and demonstrably effective, maintaining a consistent state of control.
• Provide sterility assurance oversight for aseptic processing operations, including gowning qualification, aseptic behaviors, personnel training, and cleanroom practices.
• Collaborate cross-functionally with Operations, QC Microbiology, Engineering, and Validation to establish and maintain environmental monitoring, clean util-ity, cleaning, and sanitization programs, including justified alert/action limits and response strategies.
• Review, trend, and interpret microbiological and environmental monitoring data to identify adverse trends, emerging risks, and opportunities for risk reduction.
• Lead or provide expert input into microbiological investigations, contamination events, sterility failures, and environmental excursions, ensuring thorough root cause analysis and effective CAPAs.
• Ensure CAPAs are timely, sustainable, and verified for effectiveness, with documentation suitable for FDA and EMA inspection.
• Provide technical oversight for microbiological method transfers, validation, and verification, ensuring methods are fit for intended use.
• Act as the primary Sterility Assurance Subject Matter Expert during FDA, EMA, and other regulatory inspections and audits, presenting contamination control strategies, data trending, investigations, and risk assessments.
• Promote a strong contamination control culture through routine floor presence, coaching, training, and proactive quality engagement.
• Support continuous improvement initiatives and ensure sterility assurance considerations are embedded within change management and validation activities.

Education & Experience
• Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline (Master's degree preferred).
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical manufacturing within a GMP environment.
• Demonstrated experience supporting aseptic sterile manufacturing operations.
• Prior experience in microbiology, sterility assurance, or contamination control roles required.
• Strong working knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1 (2022), 21 CFR Parts 210/211, and ICH Q7, Q9, and Q10.
• Proven experience supporting FDA and/or EMA regulatory inspections.

Technical & Professional Competencies
• Ability to apply Quality Risk Management (ICH Q9) principles to sterility assurance and contamination control decisions.
• Strong analytical and data-trending skills with the ability to scientifically justify controls, mitigations, and conclusions.
• Experience leading complex investigations and driving effective, sustainable CA-PAs to closure.
• Strong communication and influencing skills, including direct interaction with regulators and auditors.
• Ability to balance regulatory compliance, product quality, and operational efficiency.

Working Conditions
• Work in classified cleanroom environments requiring aseptic gowning and strict contamination control practices.
• Travel may be required to support vendor qualification activities, FAT/SAT execution, and regulatory or client audits.
• Flexibility to support extended hours or weekend work during validation, inspections, or critical manufacturing activities.