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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Expert - Sterility Assurance, Sterilization Validation

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHalle, GermanyIn-person

About the Job

Requirements

  • A Bachelor's or Master's degree in engineering, microbiology, biotechnology, pharmaceutical technology, or a comparable technical field.
  • A strong understanding of sterilization and decontamination technologies.
  • An understanding of microbiological fundamentals and process-control concepts.
  • Experience in statistical data analysis and trend monitoring of validation data.
  • Knowledge of risk-management methods and validation standards.
  • Experience with validation activities for sterilization and decontamination processes in the medical-device, pharmaceutical, or biotechnology industries, and experience supporting regulatory inspections and quality audits.
  • At least 3–5 years of professional experience in validation, quality assurance, production, or sterilization processes in regulated industries.
  • Good spoken and written English.

Responsibilities

  • Ensure regulatory requirements are met for sterilization and decontamination process validation at the site, and represent the department in internal and customer projects.
  • Optimize validation systems to reflect current technology and regulatory requirements.
  • Create and maintain validation instructions and report templates.
  • Present validation concepts and results during audits and inspections, and address resulting audit findings.
  • Provide technical support in preparing submission documents.
  • Write validation proposals for contract manufacturing.
  • Provide technical support to production for deviations and change controls in sterilization.
  • Create and maintain risk analyses for sterilization validation.
  • Create and maintain trending tools for validation results.
  • Build and maintain regulatory intelligence for sterilization validations.
  • Contribute to cross-functional projects and process-optimization initiatives.
  • Plan, coordinate, conduct, document, and evaluate revalidations.
  • Create validation plans and reports.
  • Develop loading plans for isolators and conduct corresponding training for production employees.

About the Company

Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.

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