Category: Validation

Employment Type: Contract To Hire

Reference: BH-373764

Yoh is hiring a Sr. Validation Engineer for our well-established client in Indianapolois, IN. The mission with this client is to enable our customers to make the world healthier, cleaner, and safer. They run the world's largest clinical packaging operation and the clinical trials facilities are strategically placed around the world to accommodate local and regional sourcing needs.

Location: Indianapolis, IN (On Site)
Type: 9 month Contract to Hire
Compensation: $35-40/hour DOE
Schedule: M-F, 8am-5pm

Responsibilities:

• Write, review, and implement project validation protocols for standard & customized systems.
• Prepare validation summary reports for completed protocols.
• Conduct deviation investigations, such as validation failures, complaints, and hold investigations.
• Identify & implement the appropriate corrective actions.
• Author operational guidance documents (SOP/WI/JA/FORM).

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

• BS Degree in Engineering or related field.
• 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.
• Pharmaceutical experience required.