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- 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 the 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.
- Assess and define assigned validation projects. Liaise between engineering and quality assurance throughout the 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 close out 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 the validated state.
- Author operational guidance documents (SOP/WI/JA/FORM) and conduct training
- Partner with the quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance
- 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 includes the development and execution of FAT, SAT, and IQ/OQ protocols required.
- Experience with DeltaV or a similar automation system is required.
- Experience working with Trackwise, Maximo, and other electronic document management systems is required.
- Experience applying Data Integrity Principles (ALCOA) as part of standard work is 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
- 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.
- A diligent collaborator who is 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.
Senior Validation Engineer - Indianapolis, United States - TekWissen LLC
Description
Job Description
Job DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.Position: Senior Validation EngineerLocation: Indianapolis, IN Duration: 9 Months Job Type: Contract Work Type: Onsite Shift: Monday to Friday - 08:00 AM to 05:00 PMHow will you make an impact?