Operations Engineer II

As an Operations Engineer II at Azzur Cleanrooms on Demand™, your primary responsibilities will include providing engineering support throughout the lifecycle of equipment and facilities, conducting validation and qualification processes, and managing equipment maintenance and calibration. You’ll also generate User Requirements Specifications, participate in quality investigations, collect and analyze data for capital projects, and create or revise Standard Operating Procedures (SOPs).

To become an Operations Engineer II at Azzur Cleanrooms on Demand™, you will need a Bachelor’s degree in Engineering or a related technical field, with a Master’s preferred. Additionally, having 3-6 years of relevant experience in manufacturing or operations, especially within the life sciences sector, is essential. Strong project management skills, problem-solving abilities, and proficiency in Microsoft Office Suite will further enhance your qualifications for this role.

Candidates for the Operations Engineer II position at Azzur Cleanrooms on Demand™ will thrive if they possess a strong background in manufacturing processes, quality systems, and regulatory requirements. Relevant experience in the life sciences industry is particularly beneficial, as it equips you with the necessary insights to excel in supporting cleanroom operations.

Azzur Cleanrooms on Demand™ promotes a diverse and inclusive company culture, valuing collaboration, innovation, and creativity. The company is committed to providing professional development and fostering an environment where all employees can thrive, ensuring everyone has the opportunity to contribute and grow in their respective roles.

As an Operations Engineer II at Azzur Cleanrooms on Demand™, you can expect a competitive benefits package that includes flexible PTO, 401(k) matching, bonus eligibility, medical benefits, and paid holidays. The company’s commitment to training and development opportunities ensures that you can continue to grow your skills and advance your career.

When answering this question, highlight specific experiences where you have generated or executed IQ, OQ, and PQ protocols. Provide examples of how you approach validation processes, any challenges you've encountered, and how you resolved them.

Discuss your systematic approach to root cause analysis. Provide examples of situations where you identified a problem, what tools or methodologies you used (like Fishbone diagrams or the 5 Whys), and how your findings informed corrective actions.

Be sure to talk about a specific project where you coordinated with different teams. Mention your role, how you facilitated communication, and the outcome of the project to demonstrate your leadership and project management skills.

Explain the processes and methodologies you rely on to stay compliant with quality systems. Discuss any audits, standard operating procedures, or training programs you’ve implemented to uphold compliance and quality standards.

Share your strategies for prioritizing tasks, such as using project management tools or aligning tasks with overall company objectives. Mention how you ensure the quality and completeness of projects while meeting deadlines.

List the engineering software tools you have experience with and how you've utilized them in your past roles. Discuss how these tools helped you improve efficiency or accuracy in your work.

Outline your process for developing SOPs, including collaboration with relevant stakeholders, reviewing existing documentation, and ensuring that the SOP meets regulatory requirements. Highlight a specific instance where your SOP was implemented.

Detail your understanding and experience with risk assessment processes. Mention how you have applied FMEA in the workplace, detailing the steps you took and the outcomes of the assessments.

Pick a project where you played a critical role. Explain the project's goals, how you initiated it, the stakeholders involved, and how you ensured its success. This showcases your project management skills comprehensively.

Discuss any professional organizations, online courses, or publications you follow to stay updated. Mention how staying informed has positively impacted your work, especially in terms of compliance or innovation.