We are seeking an Senior Sterility Assurance & Contamination Control Lead to lead the comprehensive contamination control strategy within a sterile manufacturing operations. The successful candidate will be a recognized expert in GMP-regulated sterile environments, playing a critical role in ensuring the highest standards of product quality and regulatory compliance.
Your responsibilities will include:
Proven experience in a GMP-regulated sterile manufacturing environment, including for example aseptic processing, terminal sterilization, or advanced therapy products
Demonstrated leadership in designing, implementing, and continuously improving a robust, site-wide Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 and global regulatory expectations (FDA, EMA, MHRA, PIC/S)
Strong technical background in cleanroom design, qualification, and control, including state-of-the-art aseptic facility builds or major upgrades (HVAC zoning, material/personnel flows, RABS/isolator integration)
Experience with regulatory remediation in sterile manufacturing - leading or supporting the recovery of compliance status, requalification of clean areas, and system-based corrective actions under regulatory oversight
Demonstrated expertise in leading and resolving complex sterility assurance investigations: environmental or product contamination events, sterility test failures, media fill excursions, and utility-based contamination
Deep understanding of aseptic operator qualification programs, aseptic technique training, gowning qualification, and personnel monitoring in controlled environments
Familiar with quality oversight during tech transfer, facility startup, and process validation phases, ensuring sterility assurance is designed in from the outset
Strong experience in cross-functional risk assessments (e.g., FMEA, HACCP) to proactively identify and mitigate microbial risks throughout the product lifecycle
Experienced in preparing for and managing regulatory inspections and client audits with a focus on sterility assurance systems, contamination control, and aseptic practices