Sterilization Validation Engineer

Location: Austin, TX
Department: Azzur Austin, LLC

Job Description

Job Description:

Sterilization Validation Engineer:

We at Azzur Group are looking for an experienced Sterilization Validation Engineer to immediately join our Azzur Consulting: Austin team. This position is responsible for validation of sterilization processes for a tech transfer project involving temperature mapping and sterilization of new bag.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Completes validation activities of writing and executing protocols, performing qualification and validation status assessments with guidance from more experienced engineers and managers.
  • Write and execute installation qualification, operational qualification, and performance qualification protocols; requirements trace matrices, summary reports, and validation plans.
  • Utilize Ellab temperature monitoring probes and software to perform temperature monitoring during sterilization cycles.
  • Be on the manufacturing floor and work with various disciplines to utilize saturated steam sterilization equipment. 
  • Occasionally directed in several aspects of the work and is generally independent and collaborative in nature.
  • Completes intermediate to advanced projects with some guidance from more experienced engineers and managers
  • Execute validation activities for manufacturing equipment, utilities, and facilities validation to support the validation and tech-transfer projects.
  • Write validation plans, protocols, and reports for specific projects.
  • Conduct validation risk assessments related to specific projects, facilities, and products.
  • Work independently to collect, organize, and evaluate validation data and keep validation management informed of progress and any obstacles.
  • Works on problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
  • Largely self-directed after work is assigned.
  • May solicit input from senior level engineers.
  • Uses creative approaches in solving complex problems.
  • Integrates subsystems and components in total systems design.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
  • Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.
  • Work on special projects as they arise.

QUALIFICATIONS AND REQUIREMENTS:
  • Bachelor's degree from an accredited college or university is required
  • 2-7 years of validation, science/technical or engineering background required, pharmaceutical validation or engineering experience preferred.
  • Has a solid understanding of validation and regulatory requirements.
  • Understands validation lifecycle documentation and the approval process including change control of existing systems.
  • Requires the ability to make significant decisions directly impacting the success of one or more projects, or adjacent work groups/functions.
  • Tech-transfer, process and cleaning validation knowledge.
  • Must be familiar with temperature mapping, aseptic filling or terminal sterilization processes.
  • Must have working knowledge of steam sterilization process including the critical process parameters and critical quality attributes.
  • Preferred: Ellab data logger thermocouple/validation software experience

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

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:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

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