Validation Engineer

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 for and 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.

Qualifications:

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.

Preferred Qualifications:

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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