Department: Azzur San Francisco, LLC
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.
- Develop engineering deliverables including: Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications
- Implement system modifications under cGMP change control
- Develop and execute Site and Factory Acceptance Tests (S/FAT), commissioning protocols, and qualification protocols
- Develop robust calibration and preventative maintenance plans
- Lead investigations into system deviations and implement corrective actions and preventative actions
- Assist lead engineers in development and implementation of programs related to system qualification, asset management, project execution, and Good Engineering Practices
- Stay current with biopharmaceutical industry best practices and technologies
- Interface with various roles and departments to accomplish project goals
- Develop, evaluate, and implement engineering solutions to complex problems
- BS in Engineering, Science or equivalent technical degree
- 5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry
- Experience in pharmaceutical manufacturing, engineering, plant expansions and all phases of validation
- Experienced in the design, construction and start up (inception through routine operation) of cGMP compliant facilities for the manufacture of biopharmaceutical and food products including the development of quality systems, commissioning/validation, and process design/optimization
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills
- Strong interpersonal skills and the ability to work in a team environment
- Ability to work effectively in a fast-paced multitasking environment
- Strong working knowledge of FDA and cGMP regulations and documentation practices
- Proficient in Microsoft Word, Excel, PowerPoint
- Ability to work for multiple clients throughout the region
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.