Senior Sterility Assurance Validation Lead (Remote)

TEAM - Total Engine Asset Management; United Arab Emirates; Remote; AED 400.000 - 700.000; Vollzeit

Benefits dieser Stelle

Fully remote work

Competitive compensation

Career progression opportunities

Cross-functional collaboration

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Sterility management

Validation oversight

GMP knowledge

Regulatory compliance

Technical writing

Cross-functional coordination

Risk assessment

Ausbildung

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

Jobbeschreibung

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.