Validation Engineers/Scientists must have the ability to:
- Support commissioning and qualification activities for implementation of new facility/utility/equipment systems and manufacturing processes for pharmaceutical, medical device, and/or biologics production in a regulated environment (FDA, ISO, DEA, OSHA, etc.).
- Develop, review, and submit for final approval installation, operational, and performance qualification (IQ/OQ/PQ) protocols and final reports with minimal guidance and supervision.
- Understand and strictly follow all technical and cGMP policies and procedures to maintain substantial compliance to applicable regulations.
- Provide technical knowledge and expertise in support of pharmaceutical, medical device, and/or biologics manufacturing and packaging equipment and processes.
- Leverage understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of manufacturing processes spanning the entire product lifecycle.
- Clearly and accurately document activities across the validation life cycle as requested while following all good documentation and record keeping practices.
- 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.)
- Execute a strong understanding of safety policies.
- Be self-motivated and consistently follow instructions from project lead(s) and demonstrate the ability to work with multi-functional team to meet goals and achieve results.
- Exhibit competency with computer skills required to support data collection/analysis, comparative and statistical evaluations, and professional-level reports/presentations including graphs and charts.
- Ability to effectively interact with clients on a regular basis.
- BS in a related engineering/scientific field with 3-5 years of experience.
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 Group, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 5 core values; Integrity, Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun.
It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.
We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.
If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.