Sr. Validation Engineer
1 Edwards Way Irvine, CA 92614
- Primarily be responsible for developing and executing validation plans and protocols for manufacturing, clean room utilities and equipment across all qualification activities for complex systems and product line assemblies, ensuring that assigned projects are completed in a timely manner and in accordance with company and external regulatory standards.
- A key element of this role will be to collaborate with project stakeholders to ensure integrity of the validation process and the timely resolution of issues.
- This position will report to the Engineering Manager of Global Validation for the Valve Network.
- Experience must be hands-on execution of validations, including coordination of support technicians and cross-functional resources.
- Demonstrated ability to read manufacturing equipment drawings and equipment manuals to understand basics of new process /equipment and anticipate risk.
- Demonstrated use of a process to develop a validation strategy for manufacturing, controlled environments, equipment and software for pharmaceutical or medical device manufacturers.
- This includes the ability to estimate project timelines based on validation experience.
- Proven engineering skills and experience to validate manufacturing equipment, controlled environments and software within a FDA regulated manufacturing environment.
- Use of Microsoft Office Suite for creating documents and Minitab to perform statistics that will demonstrate stability and reliability.
- Demonstrated knowledge and use of project management, problem solving and issue resolution tools/methods.
- Hands-on experience using data logging equipment and air sampling equipment.
- Experience directing and overseeing technicians to support validation execution of protocols and methodologies to minimize deviations during execution.
- Experience in Autocad and converting supplier drawings to alternate templates is preferred.
- Excellent writing skills.
- Communication and Interpersonal skills at all levels of employees, suppliers, and consultants to support professional excellence.
- Self-motivated with tangible solid contribution, a calculated assertive risk taker and change agent.
- A Bachelor' s degree in engineering or science is required with minimum 8 years experience, or equivalent hands-on experience developing validation strategy and executing validations.