Equal Employment Opportunity/M/F/disability/protected veteran status
Azzur Group
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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Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values.
