Senior Sterility Assurance Validation Specialist

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 Role

The Senior Sterility Assurance Validation Specialist is responsible for providing technical oversight, validation documentation review, and compliance support for sterilization processes and contamination-control systems used in pharmaceutical, biotechnology, and medical device manufacturing. The role focuses on sterilization validation strategies, process qualification, microbiological control, validation data assessment, deviation review, and lifecycle management. Working fully remotely, the specialist collaborates with quality assurance, microbiology, manufacturing, engineering, validation, and regulatory affairs teams to ensure that sterility assurance activities are scientifically justified, appropriately documented, and aligned with applicable regulatory and industry standards.

Key Responsibilities

• Review and evaluate sterilization validation strategies, protocols, reports, and supporting technical documentation.
• Provide technical oversight for validation programs involving moist heat, dry heat, ethylene oxide, radiation, and other applicable sterilization technologies.
• Review sterilization cycle development, qualification, and requalification documentation.
• Assess sterilization process parameters, acceptance criteria, load configurations, and documented evidence supporting process effectiveness.
• Review biological indicator, chemical indicator, and physical monitoring data generated during sterilization validation activities.
• Evaluate microbial challenge studies, bioburden assessments, and relevant microbiological test results.
• Review sterilization dose establishment and verification documentation for radiation-based sterilization processes.
• Assess ethylene oxide sterilization documentation, including cycle parameters, residual testing, aeration studies, and relevant safety considerations.
• Review steam sterilization records, temperature distribution studies, heat penetration data, and load qualification evidence.
• Support the review of aseptic processing validation, media fill documentation, and contamination-control strategies where applicable.
• Evaluate cleanroom qualification records, environmental monitoring trends, and contamination-control evidence.
• Review validation deviations, out-of-specification results, nonconformances, and investigations related to sterilization processes.
• Assess corrective and preventive action plans and monitor the effectiveness of implemented improvements.
• Support risk assessments relating to sterilization failure, microbial contamination, packaging integrity, and product sterility.
• Review sterilization validation lifecycle documentation, including change assessments, periodic reviews, and requalification requirements.
• Coordinate with engineering and manufacturing teams to assess the impact of equipment modifications, process changes, and product or packaging changes.
• Review packaging validation and sterile barrier system documentation, including seal integrity and package performance evidence.
• Maintain controlled validation records, technical assessments, review comments, and audit-ready documentation.
• Support internal audits, supplier assessments, regulatory inspections, and technical responses relating to sterility assurance.
• Monitor relevant updates to GMP requirements, ISO standards, and applicable pharmacopeial guidance.
• Recommend improvements to validation procedures, documentation standards, contamination controls, and sterility assurance governance.

Qualifications and Experience

• Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Biomedical Engineering, Chemical Engineering, or a related discipline.
• A master's degree or relevant professional certification in validation, pharmaceutical quality, or microbiology is an advantage.
• Significant experience in sterility assurance, sterilization validation, pharmaceutical microbiology, or medical device validation.
• Strong understanding of sterilization technologies, including moist heat, dry heat, ethylene oxide, and radiation.
• Experience reviewing sterilization validation protocols, qualification reports, microbiological studies, and process monitoring records.
• Knowledge of biological indicators, chemical indicators, bioburden testing, microbial challenge studies, and sterility assurance principles.
• Familiarity with GMP requirements, ISO 11135, ISO 11137, ISO 17665, and other applicable sterilization standards.
• Understanding of aseptic processing, contamination-control strategies, cleanroom qualification, and environmental monitoring.
• Experience with validation lifecycle management, risk assessments, deviation investigations, change control, and CAPA processes.
• Knowledge of sterile barrier packaging validation and relevant packaging integrity requirements.
• Familiarity with electronic quality management systems, validation documentation platforms, and laboratory information systems.
• Strong analytical, technical review, and scientific documentation skills.
• Excellent attention to detail and ability to assess complex validation datasets.
• Strong communication and cross-functional coordination abilities.
• Ability to work independently and collaborate effectively with technical and quality teams in a fully remote environment.

What We Offer

• Fully remote working arrangement within the stated UAE-based role framework.
• Opportunity to support critical sterility assurance and validation programs.
• Collaboration with pharmaceutical, biotechnology, medical device, and quality professionals.
• A professional environment focused on patient safety, process reliability, and regulatory compliance.
• Opportunities for continued development in sterilization science, validation, and pharmaceutical quality systems.

How to Apply

Interested candidates should submit an updated CV highlighting their sterility assurance experience, sterilization validation expertise, microbiological knowledge, and familiarity with relevant GMP and ISO standards.

Application Subject: Application – Senior Sterility Assurance Validation Specialist (UAE Remote)

• Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. This is a fully remote technical oversight and documentation review role. Physical sterilization activities, biological indicator preparation, microbiological testing, equipment operation, cycle execution, cleanroom inspections, and on-site qualification activities must be performed by qualified local personnel in appropriately equipped facilities. Formal validation approvals, batch-release decisions, regulatory submissions, and statutory sign-offs must be completed by appropriately qualified and authorized personnel in accordance with applicable requirements.