The Process Control Engineer is responsible for execution of computer validation program and lifecycle management of automation systems for AZ Biopharmaceutical Development (BPD) facilities including analytical test laboratories, quality control laboratories, manufacturing facilities and clinical manufacturing facilities.
Education and Experience Requirements:
- Subject Matter Expert (SME) for validation of computer systems
- Lifecycle validation management of computer systems including validation, periodic review and maintenance and decommissioning
- Reviews global standards and creates site level procedures adopted for validation in a clinical manufacturing environment
- Assesses capital equipment design and budgets appropriate resources to the projects.
- Executes validation for manufacturing equipment, analytical equipment, infrastructure, spreadsheets, code changes, etc.
- Provides validation guidance to the remaining process control, infrastructure, project engineers and scientists.
- Executes work in alignment with quality, safety and sustainability standards.
- Installs automation systems
- Manages validation timelines.
- Performs quality/safety investigations on computer systems
- Performs change control
- Directs outside equipment/service providers, Oversees the work of contractors
- Writes user requirements, specifications, test scripts, and recipes
- Develops and maintains maintenance programs for systems
- Resolves computer issues
- Bachelor's degree in Engineering, Computer Sciences or an equivalent combination of education and 1-2 years of experience.
- GMP and GDP experience in a biotech or sterile pharmaceutical automation environment
- Validation/Quality review computer systems.
- Knowledge of data integrity regulations including21CFR part 11 compliance