Validation Engineer II - Katalyst Healthcares & Life Sciences
Pasadena, CA 91101
About the Job
Responsibilities:
- The Validation Engineer II will be involved in the implementation and execution of the equipment qualification and cleaning validation programs to ensure phase appropriate operational readiness aligned with regulatory expectations at the internal manufacturing sites.
- The position will be responsible for representing validation on project teams and ensuring completion of validation projects within strict timelines.
- The Validation Engineer II will participate in qualification and validation activities for equipment, facilities, utilities, automation control systems, and cleaning processes and will ensure their maintenance in a validated state.
- Additionally, the role may support internal/external audits and other lifecycle activities to support the validation program.
- Manage validation tasks and projects of limited scope with some guidance.
- Produce detailed validation reports with some guidance.
- Apply the tools needed to develop solutions, analyze data, and identify trends with some guidance.
- Associates degree with minimum of 4 years of relevant validation experience, bachelor's degree with at least 2 years of relevant validation experience, or a master's degree.
- Basic understanding of cGMP requirements for pharmaceutical manufacturing
- Perform activities for qualification of process equipment, automation control systems, support systems, and utilities in a multiproduct facility.
- Perform activities to support cleaning validation.
- Coordinate with other functions and/or external vendors to ensure completion of validation tasks and other lifecycle deliverables as needed.
- Summarize observed issues, design, and validation activities independently.
- Manage validation tasks and projects of limited scope with some guidance.
- Produce detailed validation reports with some guidance.
- Apply the tools needed to develop solutions, analyze data, and identify trends with some guidance.
- May contribute in inspections, audits, and regulatory filings.
Source : Katalyst Healthcares & Life Sciences