Senior Validation Engineer - Indianapolis, United States - Infojini
Description
Job Title Senior Validation Engineer
Location Indianapolis, IN 46221
Duration 9+ months contract to hire position
Shift Hours Mon Fri 8AM to 5PM
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 sites validation strategy.
What will you 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
Minimum Education and Experience:
Bachelor of Science Degree in Engineering or another scientific subject area from an accredited College or University.
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 teams 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.
Company Overview:
Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.
Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.