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Validation Engineer
4 months ago
We are looking for a Validation Engineer with a minimum of 3 years of experience who
possesses a strong understanding of autoclave cycle development and syringe fill/finish
principles. The ideal candidate will be responsible for developing and optimizing autoclave
sterilization cycles forand executing qualification protocols for syringe
sterilization processes. The role requires collaboration with cross-functional teams to ensure
compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and optimize autoclave sterilization cycles (cycle development) ensuring compliance with regulatory requirements and industry
standards. - Design and execute qualification protocols for syringe sterilization processes, including performance qualification (PQ) and process validation.
- Conduct risk assessments and implement mitigation strategies to address potential
sterilization process deviations or failures. - Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to support product development and commercial manufacturing
activities. - Stay current with industry trends and best practices related to sterilization technologies and regulatory requirements.
- Bachelor's degree in Engineering or related field; Master's degree preferred.
- Minimum of 3 years of experience in validation engineering or related field.
- Strong understanding of autoclave qualification and syringe fill/finish principles.
- Experience with sterilization process optimization and validation in a pharmaceutical or medical device manufacturing environment.
- Knowledge of regulatory requirements, including FDA and ISO standards.
- Excellent communication and collaboration skills.
- Ability to work effectively in a cross-functional team environment.
- Experience with statistical analysis and validation software.
- Six Sigma or Lean Manufacturing certification.
- Experience with risk management tools such as FMEA.
- Familiarity with GMP and GDP guidelines.
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