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

We are seeking an experienced Senior Sterility Assurance Validation Specialist to provide technical leadership and remote oversight for sterilization validation, aseptic process assurance, contamination control, and microbiological quality systems within pharmaceutical and medical device environments. The role focuses on reviewing validation strategies, assessing sterilization processes, evaluating microbiological data, and ensuring that sterility assurance activities align with applicable regulatory and industry standards. The successful candidate will work closely with quality assurance, microbiology, engineering, manufacturing, and regulatory teams to support robust validation programs and maintain effective contamination control practices.

Key Responsibilities

• Lead the technical review and oversight of sterilization validation strategies for pharmaceutical products, medical devices, components, and relevant manufacturing materials.
• Review validation protocols, reports, risk assessments, and supporting technical documentation for sterilization processes.
• Provide specialist guidance on moist heat, dry heat, ethylene oxide, radiation, and other applicable sterilization technologies.
• Evaluate sterilization cycle development, qualification, performance qualification, and requalification documentation.
• Review sterilization process parameters, acceptance criteria, and evidence supporting process effectiveness.
• Assess biological indicator and chemical indicator data, including their suitability and interpretation.
• Provide technical oversight of biological indicator studies, microbial challenge assessments, and sterilization efficacy evaluations.
• Review aseptic processing validation activities, including media fill simulations and associated investigation reports.
• Assess environmental monitoring programs, cleanroom microbiological data, and contamination control trends.
• Review cleaning, disinfection, and microbial control validation documentation where relevant to sterility assurance.
• Support the development and evaluation of contamination control strategies across manufacturing operations.
• Review bioburden testing, endotoxin testing, sterility testing, and related microbiological quality data.
• Evaluate deviations, out-of-specification results, process failures, and sterility assurance incidents.
• Lead or support root cause analysis and corrective and preventive action (CAPA) assessments.
• Assess the impact of equipment changes, process modifications, facility changes, and product changes on validated sterilization processes.
• Review validation lifecycle documentation, including periodic reviews, change controls, and revalidation assessments.
• Provide technical guidance on applicable GMP requirements, ISO standards, and relevant regulatory expectations.
• Collaborate with quality assurance, microbiology, engineering, validation, manufacturing, and regulatory affairs teams.
• Support internal audits, external inspections, and regulatory readiness through technical documentation review.
• Prepare validation summaries, technical assessments, risk reports, and management updates.
• Identify opportunities to improve validation practices, contamination control, and sterility assurance systems.

Qualifications and Experience

• Bachelor's or master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Biomedical Engineering, Chemical Engineering, or a related discipline.
• Significant experience in sterility assurance, sterilization validation, microbiological quality, or pharmaceutical validation.
• Strong understanding of sterilization principles and validation requirements for pharmaceutical or medical device applications.
• Experience reviewing moist heat, dry heat, ethylene oxide, or radiation sterilization validation programs.
• Knowledge of biological indicators, chemical indicators, microbial resistance, and sterilization process challenges.
• Familiarity with aseptic processing, media fill validation, and contamination control strategies.
• Experience evaluating environmental monitoring, bioburden, sterility testing, and microbiological trend data.
• Understanding of GMP requirements and relevant guidance, including applicable FDA, EMA, EU GMP Annex 1, and ISO standards.
• Familiarity with ISO 11135, ISO 11137, ISO 17665, and other relevant sterilization standards, as applicable to the process.
• Experience reviewing validation protocols, qualification reports, risk assessments, and controlled procedures.
• Knowledge of validation lifecycle management, change control, deviation management, and CAPA processes.
• Ability to interpret microbiological and sterilization data and identify potential process weaknesses.
• Strong understanding of contamination control, cleanroom practices, and microbiological risk management.
• Excellent technical writing, documentation review, and analytical problem-solving skills.
• Ability to communicate technical findings and coordinate multidisciplinary teams remotely.
• High attention to detail, data integrity, and regulatory compliance.

What We Offer

• Fully remote working arrangement within the UAE employment framework, subject to applicable eligibility and authorization requirements.
• Opportunity to contribute to pharmaceutical and medical device sterility assurance programs.
• Collaboration with multidisciplinary quality, engineering, microbiology, and validation professionals.
• Professional development in sterilization technologies, validation science, and regulatory compliance.
• A senior technical role with opportunities to strengthen quality systems and contamination control practices.

How to Apply

Interested candidates should submit an updated CV highlighting their sterility assurance experience, sterilization validation expertise, microbiological quality background, and relevant technical qualifications.

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

• Important Note: This is a fully remote technical oversight, validation review, and documentation role. Physical sterilization studies, equipment operation, laboratory testing, facility inspections, and on-site qualification activities must be performed by appropriately qualified personnel at authorized facilities. The specialist may provide remote technical guidance, data review, validation assessment, and investigation support. Formal validation approvals, regulated quality decisions, and regulatory submissions must be completed by personnel with the required professional authorization. Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.