Sr Automation Validation Engineer
| Company | Kyowa Kirin North America |
|---|---|
| Location | Sanford, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in a technical field required
- Formal GMP and Safety training is essential
- At least 7 years of experience in Automation Validation or Automation for BioPharma Manufacturing or Capital Projects
- Thorough understanding of CSV
- Experience with validation of automated systems in a biopharmaceutical manufacturing facility is essential
- Background in cGMP regulations, GAMP, EHS
Responsibilities
- Develop the establishment of the CSV and automation validation program for the Sanford site
- Lead the validation of the selected Automation in the implementation of site automated systems
- Drive execution of computer system validation and automation system validation
- Lead ongoing maintenance and continuous improvement of all qualified equipment and computerized systems
- Lead future capital projects, expansions, or technological implementations
Preferred Qualifications
- Leadership experience in Automation or Validation is preferred
- Experience with Tech Transfer is a plus
- Experience with capital project validation and/or starting up and operating a biopharma manufacturing facility is a plus