Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Development and editing of SOP
- Development and execution of validation test procedures
- Development of project plans, as appropriate
- Thermal mapping of temperature controlled chambers, warehouses, and SIP processes
- Technical presentations
- Technical report writing
- Data Analysis
- P&ID walkdowns
- BS in Engineering, Science or equivalent technical degree.
- 5+ years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
- Experience in writing and executing protocols including systems such as process validation, utilities, manufacturing equipment
- Working knowledge of FDA and cGMP regulations and documentation practices
- Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
- Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
- Ability to define problems, collect data, establish facts and draw valid conclusions
- Proficient in Microsoft Word, Excel, and PowerPoint
- Mathematical Skills, Computer Skills including Microsoft Word and Excel, Statistical analysis skills
- Experience with temperature mapping
- Basic knowledge of laboratory validation
- Basic knowledge of computer system validation
- Project management skills
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.