Sterility Assurance Specialist

Sterility Assurance Specialist – Sterile GMP ManufacturingA leading pharmaceutical development organization is seeking a Sterility Assurance Specialist to drive contamination control and sterility assurance across aseptic manufacturing operations. This role is instrumental in shaping a sterility-focused culture and ensuring compliance with GMP and regulatory standards, including Annex 1 (2022), FDA, EMA, and ISO classifications.Key ResponsibilitiesFoster a sterility-focused mindset across teams by implementing standards and controls that support regulatory compliance in facility, utility, equipment, and procedural design.Provide expert guidance on facility layout, cleanroom design, utilities, equipment selection, and process flows to minimize contamination risks.Oversee aseptic manufacturing of parenteral drug products, including lyophilized, solution, and suspension forms.Lead validation and qualification of critical systems and processes, including cleaning, sterilization, and utilities.Develop and sustain comprehensive contamination control strategies aligned with Annex 1 and industry best practices.Implement and maintain cleanroom classifications (ISO/FDA/EU) and enforce strict gowning and cleanroom behaviour protocols.Optimize aseptic operations using barrier technologies (RABS, isolators) and ensure compliance across Grade A/B/C/D environments.Design and manage environmental monitoring programs (viable and non-viable), including setting alert/action levels and investigating excursions.Oversee sterilization systems (autoclaves, SIP, CIP) to ensure validated and effective operation.Plan and execute media fill simulations, including investigation and resolution of failures.Support container closure integrity testing (CCIT) and related sterility assurance activities.Participate in cleanroom qualification lifecycle stages (DQ/IQ/OQ/PQ) and review/approve validation protocols.Develop and deliver training programs on aseptic techniques, gowning, cleanroom behaviour, and incident response.Maintain sterility assurance documentation including SOPs, protocols, validation reports, and investigation records.Lead risk assessments and troubleshooting during deviations, facility/process changes, and production ramp-up.Act as a subject matter expert during regulatory inspections, audits, and investigations related to sterility assurance.Candidate ProfileBSc/MSc in Microbiology, Pharmacy, or a related discipline.Extensive experience in sterility assurance within the pharmaceutical industry.Deep knowledge of GMP, contamination control, aseptic processing, validation, and regulatory guidelines.Strong technical expertise in cleanroom operations, sterilization technologies, and environmental monitoring.