Department: Azzur of North Carolina, LLC
Validation Engineers will plan, implement and monitor the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. They measure and analyze the equipment and processes. They audit and calibrate equipment and processes. They create document trails that show the equipment is designed to provide consistent results, ensuring the highest quality products.
Validation Engineers must have the ability to:
- Support equipment installation and process implementation of new equipment /processes relevant to manufacturing, packaging and utility systems in a regulated environment (FDA, DEA, OSHA, etc.) and strictly follow procedures.
- Basic understanding of pharmaceutical manufacturing and packaging equipment and processes.
- Basic understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of pharmaceutical processes spanning the entire product life-cycle.
- Clearly and accurately document activities across the validation life cycle as requested.
- Assist with developing specifications as needed for equipment / systems.
- Work closely with equipment vendors to ensure thorough and accurate documentation is gathered during the installation and start up processes.
- Provide input to test parameters, process parameters, validation documentation
- Develop critical parameters needed for follow up validation testing of equipment and processes.
- Perform basic to high-level mathematical calculations to support process development
- Monitor manufacturing and packaging processes during initial production run to assess any technical process issues.
- Assist in writing validation and technical improvement reports.
- Provide input to Master Batch Records (MBRs). (equipment, critical process parameters, in-process tests, etc.)
- Basic understanding of safety policies.
- Self-motivated and able to follow instructions from project lead(s) and the ability to work with multi-functional team to meet goals and achieve results.
- Basic computer skills. Collect data, conduct comparative and statistical evaluations and present it in a professional manner including graphs and charts.
- Ability to interact with clients on a regular basis.
- BS in a related engineering field with 10+ years of experience.
- Will be the subject matter expert on the project.
- Ability to manage/supervise a team of engineers.
- Will require project management experience.
- Work is generally independent and collaborative in nature.
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!