Automation Engineer - Computer Validation - BPD
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals
26 days ago



Job Description

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.

Responsibilities:

  • 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


Education and Experience Requirements:
  • 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




Share this job with the community

Click a community link below, and then social share the Automation Engineer - Computer Validation - BPD job.


African American Job Search Logo
Asian Job Search Logo
Disabled Job Seekers Logo
Hispanic Job Exchange Logo
LGBT Job Search Logo
Seniors to Work Logo
US Diversity Job Search Logo
Veteran Job Center Logo