- 5-8 years in a CSV / CQV environment, writing and executing IQ, OQ, and PQ protocols in support for the commissioning and qualification of GLP / GMP laboratory equipment..
- At least 5-7 years of experience with the successful validation, qualification, or requalification of laboratory and / or manufacturing equipment in a cGxP regulated environment. Examples of equipment are; incubators, plate readers, cell counters, refrigerators / freezers, mixers, biosafety cabinets, bioreactors, filtration, and QC (quality control) equipment.
- Write deviations associated with protocol execution and work with team of engineers to resolve.
- Author qualification reports for executed protocols.
- Write or revise existing protocols as needed based on new and / or previously executed equipment.
- Work with Facilities, Engineering, and QC personnel to obtain documentation necessary for equipment release.
- Work with senior Azzur Engineers on site for guidance on project and protocol execution.
BS Engineering or related discipline
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!
Azzur Group is an equal opportunity employer and promotes 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.