Expert Gamma Sterilization

Responsibilities

The subject of the assignment is the technical creation, evaluation, documentation, and further development of procedures, strategies, and proofs in the areas of:

The service includes the development of technical concepts, assessments, opinions, and documentation drafts, as well as the technical assessment of test results from external laboratories and service providers. The technical design of the work results will take into account the client's requirements and the relevant normative and regulatory specifications.

The services will be provided considering the applicable regulatory requirements, relevant standards, and the client's provided specification documents and procedural instructions.

Laboratory work, sample collection, test execution, analyses, or other operational activities on products, systems, or test facilities are not part of the assignment.

The final review, approval, release, and implementation of all work results remain exclusively with the client.

The services will be provided professionally, comprehensibly, and documented based on the current state of science, technology, standardization, and regulatory requirements. The scope of services includes the creation of technical work results, documentation drafts, and written, data-based status and conformity assessments for review and release by the client.

2.1 Bioburden Testing on Medical Devices In the area of bioburden testing, the scope of services includes in particular:

2.2 Gamma Sterilization according to ISO 11137

In the area of gamma sterilization, the scope of services includes in particular:

2.3 Sterility Testing within the Scope of Sterilization Validation In the area of sterility testing, the scope of services includes in particular:

The following can be created and provided as work results:

Provision will be made in electronic form for further review, evaluation, and release by the client.

The client provides the internal system and document landscape exclusively as technical infrastructure for data exchange and the provision of work results. The development of the services will be carried out using the service provider's resources.

Project No.:

1083984

Project Title:

Job Type:

Freelance

• Subject of the Assignment
• Bioburden testing on medical devices
• Gamma sterilization processes according to ISO 11137
• Sterility testing within the scope of validation and maintenance of sterilization processes
• Validation strategies and their optimization
• GMP and regulatory compliant documentation and technical reports
• Scope of Services
• Creation, review, and revision of test plans, evaluation documents, and result reports
• Technical evaluation of preliminary studies, test approaches, investigation designs, and test results
• Assessment of the suitability and significance of applied analysis and proof methods
• Technical specification and development of test methodologies for technical coordination with external test laboratories and service providers
• Creation and revision of risk-based assessments
• Development of technical justifications, opinions, and scientific evaluations
• Technical assessment of compliance with normative and regulatory requirements
• Written documentation of technical assessments and conclusions
• Development and elaboration of validation strategies and validation concepts
• Creation, review, and revision of validation plans and validation reports
• Technical evaluation of dose setting, dose audits, dose confirmations, and revalidations
• Assessment of experimental designs and results from external service providers and test laboratories
• Creation and revision of risk-based assessments related to sterilization processes
• Formulation of technical justifications for procedures and proposals for acceptance criteria and decision bases
• Documentation of technical assessments for normative and regulatory conformity
• Creation of optimization concepts for the further development and harmonization of existing procedures, considering operational and regulatory requirements
• Creation, review, and revision of test plans, validation plans, and final reports
• Evaluation of the suitability, significance, and regulatory acceptance of applied sterility test methods
• Technical assessment of method developments, preliminary tests, and validation studies
• Assessment and optimization of analysis and test strategies for implementation by involved test laboratories
• Analytical assessment of test results, deviations, trends, and risk-based decision bases
• Creation and revision of scientific evaluations, risk assessments, and opinions
• Development of technically suitable proof and test strategies for the validation and maintenance of sterilization processes
• Documentation of technical conclusions and reports
• Documentation and Work Results
• Test and validation plans
• Risk analyses and risk assessments
• Technical evaluation reports
• Scientific justifications and opinions
• Result reports
• Gap analyses
• Evaluation protocols
• Documentation drafts for regulatory proofs The respective service is considered rendered upon provision of the agreed work result in the intended target system.
• Expert Gamma Sterilization

Requirements

Additional Information:

SOLCOM is one of the leading technology service providers in software development, IT, and engineering. For over 20 years, we have been working as partners with globally operating top companies in all industries and are active worldwide where innovation is decisive.

• Profound expertise in microbiology, sterilization processes, sterilization validation, or comparable fields.
• Several years of practical experience in the regulated environment of the medical device industry, particularly in the area of microbiological testing and sterilization processes.
• Demonstrable experience in the technical evaluation and documentation of bioburden tests.
• Demonstrable experience in planning, evaluating, and documenting validation activities for gamma sterilization processes.
• Experience in the technical assessment of test results, validation data, and laboratory reports from external test laboratories or service providers.
• ISO 11137 (Sterilization of health care products – Radiation sterilization)
• ISO 11737-1 (Determination of bacterial enumeration on products, devices and components)
• ISO 11737-2 (Sterility testing of medical devices – Part 2: Tests for sterility)
• ISO 13485
• Regulation (EU) 2017/745 on medical devices (MDR)
• GMP requirements in the relevant application area
• Experience in applying risk-based methods and assessment approaches in a regulated environment
• Experience in creating and revising GMP-compliant documentation.
• Experience in creating validation plans, validation reports, risk analyses, and risk assessments.
• Experience in developing scientific justifications, technical assessments, and regulatory documentation.
• Ability to comprehensibly document and technically assess complex microbiological and sterilization-related issues.
• Experience in evaluating deviations, investigation results, trends, and validation data.

Project details

Germany

10/15/2026

5 months

• Start: flexible
• Duration: 5 Monate
• Remote: onsite
• Location: Deutschland, Deutschland, DE
• Languages: German