Senior Sterility Assurance Validation Specialist
UAE/Dubai
Listed on 2026-11-04
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Title:
Senior Sterility Assurance Validation Specialist
Location: United Arab Emirates (Remote)
Employment Type: Full-Time
Work Arrangement: 100% Remote — Work From Home
Level: Senior
About the RoleWe are seeking an experienced Senior Sterility Assurance Validation Specialist to provide technical oversight and validation support for sterilization processes, contamination control strategies, and sterility assurance programs within pharmaceutical, biotechnology, and medical device environments. The successful candidate will review validation protocols, assess technical data, evaluate process performance, and ensure that sterilization and contamination control activities align with applicable regulatory requirements and quality standards.
This fully remote position focuses on validation strategy, technical documentation review, risk assessment, deviation investigation support, and cross-functional coordination. The specialist will collaborate with quality assurance, microbiology, manufacturing, engineering, validation, and regulatory affairs teams to maintain robust sterility assurance systems.
Key Responsibilities- Develop, review, and maintain sterility assurance validation strategies, procedures, and technical documentation.
- Provide technical oversight for sterilization validation programs involving applicable methods such as moist heat, dry heat, ethylene oxide, radiation, and sterile filtration.
- Review sterilization validation protocols, qualification plans, execution records, and final reports.
- Assess sterilization process performance, cycle parameters, acceptance criteria, and validation outcomes.
- Review biological indicator, chemical indicator, and physical monitoring data where applicable to the sterilization method.
- Support the evaluation of microbial challenge studies, sterilization efficacy data, and process lethality calculations.
- Review aseptic processing qualification documentation, including relevant media fill simulations and associated investigations.
- Evaluate sterile filtration validation packages, including bacterial retention studies, filter compatibility, and integrity testing documentation.
- Support the development and review of contamination control strategies for sterile manufacturing operations.
- Assess cleanroom qualification records, environmental monitoring trends, and microbiological control data in collaboration with relevant technical teams.
- Review sterilization requalification schedules and assess the need for additional validation following process, equipment, or product changes.
- Participate in risk assessments relating to microbial contamination, sterilization failures, and potential impacts on product quality.
- Support investigations into sterilization deviations, failed validation runs, environmental excursions, and sterility assurance concerns.
- Assist with root cause analysis, corrective and preventive actions (CAPA), and effectiveness checks.
- Ensure validation documentation aligns with applicable GMP requirements, recognized industry standards, and approved internal procedures.
- Review change controls affecting sterilization cycles, equipment, packaging configurations, manufacturing processes, and critical utilities.
- Prepare technical assessments, validation summaries, risk evaluations, and management reports.
- Support internal audits, external inspections, and regulatory assessments by coordinating validation evidence and technical responses.
- Provide remote technical guidance and training to validation, microbiology, and quality assurance personnel.
- Recommend improvements to validation governance, contamination control practices, and lifecycle management processes.
- Bachelor's or master's degree in Microbiology, Pharmaceutical Sciences,…
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