Validation Engineer

How will you make an impact?

The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. In this role, you will also create and implement the site’s validation strategy.

What you will do

• Assess and define assigned validation projects. Liaise between engineering and quality assurance throughout validation lifecycle of packaging equipment and data historian network.

• Develop validation strategy based on URS and pFMEA

• Writing, reviewing, and implementing project validation protocols for standard & customized systems.

• Raise discrepancies and closeout test documentation.

• Prepare validation summary reports for completed protocols

• Conduct deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.

• Applying structured problem-solving tools, work with Operations to resolve technical issues and rationalize impact to validated state.

• Author operational guidance documents (SOP/WI/JA/FORM) and conduct trainings

• Travel to support FAT executions

• Partner with quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance

How you will get there:

Education:

Bachelor of Science Degree in Engineering or another scientific subject area from an accredited College or University

Experience:

• Minimum of 3 years of validation experience in a regulated industry or equivalent validation experience that included the development and execution of FAT, SAT, and IQ/OQ protocols required.

• Experience with DeltaV or similar automation system preferred.

• Experience working with Trackwise, Maximo, and other electronic document management systems preferred.

• Experience applying Data Integrity Principles (ALCOA) as part of standard work preferred.

• Experience with computer systems validation, cleaning validation, and environmental monitoring preferred.

• Demonstrated understanding of cGMP, GDP, and regulatory requirements for automated systems, CPPs, and CQAs, pFMEAs

• Knowledge, Skills, Abilities

• Great teammate who enjoys working on a dynamic team and making an impact

• Driven to successfully evaluate risks, opportunities, and roadblocks to make the best decisions to achieve your goals and the team’s goals.

• Diligent collaborator whose comfortable influencing, informing, and instructing peers and members of the leadership team throughout all levels of the organization.

• Hands-on engineer with comfortability being present in and working in and around manufacturing areas and equipment.