Required skills
- Validation Specialist
- Gamma Sterilisation
- ISO 11137
- Microbiology
- Sterilisation Validation
- Medical Device Industry
- Bioburden Testing
- ISO 11737-1
- ISO 11737-2
- ISO 13485
- MDR
- GMP
Languages: German
Job description
Seeking a Validation Specialist with expertise in Gamma Sterilisation for a 12-month+ remote project starting January 2027. The role involves creating and reviewing validation plans, reports, and strategies according to ISO 11137.
Responsibilities
- Creation and review of test and validation plans as well as result reports
- Technical evaluation of test approaches, studies, validation data, and laboratory results
- Development and evaluation of validation strategies for gamma sterilisation according to ISO 11137
- Evaluation of dose settings, dose audits, dose determinations, and revalidations
- Technical evaluation and optimisation of sterility testing procedures
- Creation of risk analyses and risk-based assessments
- Preparation of scientific justifications, statements, and expert assessments
- Evaluation of normative and regulatory compliance
- Creation of gap analyses, assessment protocols, and regulatory documentation
- Evaluation of deviations, trends, and investigation results
Requirements
- Sound expertise in microbiology, sterilisation processes, and sterilisation validation
- Several years of experience in the medical device industry in a regulated environment
- Demonstrable experience with bioburden testing
- Experience in planning, evaluating, and documenting gamma sterilisation validations
- Experience in evaluating test results, validation data, and laboratory reports
- Sound knowledge of ISO 11137, ISO 11737-1/-2, ISO 13485, and MDR
- Knowledge of relevant GMP requirements
- Experience with risk-based methods and assessment approaches
- Experience in creating GMP-compliant validation plans, reports, and risk analyses
- Confident handling of scientific and regulatory documentation
Project details
January 2027
12 months +
Project ID: 15071
Application Deadline: 10/19/2026
Dear Network,
We are looking for a Validation Specialist (m/f/d) Gamma Sterilisation for our client.
https://www.constaff.com/projektbeschreibung/?positionID=15071
25 hours/week
Do you have time and interest in an exciting project?
Then we look forward to hearing from you!
Contact:
Annika Kärcher
Expert Candidate Relations
_____
Constaff GmbH - 100%OpenBook. Honest. Competent. Transparent.
- Start: ab sofort
- Duration: 6 Monate
- Remote: remote
- Location: Frankfurt am Main, Deutschland, DE
- Languages: German
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