Senior Sterility Assurance Validation Specialist

TEAM - Total Engine Asset Management; United Arab Emirates; Remote; AED 400,000 - 700,000; Full time

Benefits offered by this job

Fully remote work

Competitive compensation

Career progression opportunities

Cross-functional collaboration

Job summary

TEAM - Total Engine Asset Management is seeking a Senior Sterility Assurance Validation Specialist to provide oversight of sterilization validation, contamination control strategies, and sterility programs across pharma, biotech, and medical device environments.

You will review validation protocols, assess data, and ensure compliance with GMP and applicable ISO standards, while coordinating with QA, microbiology, manufacturing, and regulatory affairs teams in a fully remote setting.

Qualifications

• Bachelor's or master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Biomedical Engineering or related field.
• Significant experience in sterility assurance, sterilization validation, pharma validation, microbiology or QA.
• Strong understanding of sterilization principles and validation methodologies in pharma/medical devices.
• Familiar with GMP requirements and ISO standards such as ISO 11135, 11137, 17665, 13408 where applicable.

Responsibilities

• Develop and maintain sterility assurance validation strategies, procedures, and documentation.
• Provide technical oversight for sterilization validation programs (moist heat, dry heat, EO, radiation, sterile filtration).
• Review validation protocols, qualification plans, execution records, and final reports.
• Assess sterilization process performance, cycle parameters, acceptance criteria, and validation outcomes.
• Review monitoring data (biological, chemical, physical) for sterilization methods where applicable.
• Support evaluation of microbial challenge studies, sterilization efficacy data, and lethality calculations.
• Review aseptic processing qualification docs including media fills and investigations.
• Evaluate sterile filtration validation packages, bacterial retention, filter integrity testing.
• Support contamination control strategies for sterile manufacturing operations.
• Assess cleanroom qualification records, environmental monitoring trends, and microbiological data.
• Review requalification schedules and need for additional validation after changes.
• Participate in risk assessments related to contamination, sterility failures, and product quality impact.
• Support investigations into deviations, excursions, and CAPA effectiveness.
• Ensure validation docs align with GMP, standards, and internal procedures.
• Review change controls affecting sterilization cycles, equipment, packaging, and utilities.
• Prepare technical assessments, validation summaries, risk evaluations, and management reports.
• Support audits, inspections, and regulatory assessments with validation evidence and responses.
• Provide remote technical guidance and training to validation teams and QA.

Skills

Sterility management

Validation oversight

GMP knowledge

Regulatory compliance

Technical writing

Cross-functional coordination

Risk assessment

Education

Bachelor's/Master's degree in Microbiology / Pharma Sciences / Biotechnology / Chemical/Biomedical Engineering

Job description

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 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.

Qualifications and Experience

• Bachelor's or master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Biomedical Engineering, or a related discipline.
• Significant experience in sterility assurance, sterilization validation, pharmaceutical validation, microbiology, or quality assurance.
• Strong understanding of sterilization principles and validation methodologies used in pharmaceutical or medical device manufacturing.
• Experience reviewing sterilization validation protocols, qualification records, and final technical reports.
• Knowledge of applicable GMP requirements and relevant standards, such as ISO 11135, ISO 11137, ISO 17665, and ISO 13408, where applicable to the process and product.
• Familiarity with relevant FDA and international regulatory expectations for sterile medicinal products and sterile medical devices.
• Understanding of contamination control strategies, environmental monitoring, aseptic processing, and microbiological risk management.
• Experience with biological indicators, sterilization efficacy assessments, process qualification, and requalification activities.
• Knowledge of sterile filtration validation, filter integrity testing, and microbial retention principles, where relevant.
• Experience supporting deviations, out-of-specification investigations, CAPA, and change control processes.
• Familiarity with risk assessment methodologies, including failure mode and effects analysis (FMEA).
• Ability to interpret complex validation data and identify potential sterility assurance risks.
• Strong technical writing, documentation review, and analytical problem-solving skills.
• Excellent communication and cross-functional coordination abilities.
• High attention to detail and the ability to manage multiple validation projects and regulatory deadlines.
• Ability to work independently and collaborate effectively with geographically distributed teams.

What We Offer

• A fully remote, work-from-home arrangement.
• Competitive compensation based on experience and qualifications.
• Opportunities to support critical pharmaceutical quality and sterility assurance programs.
• Collaboration with multidisciplinary teams across validation, microbiology, engineering, and quality functions.
• Professional development and opportunities for career progression.