Category: Validation

Employment Type: Contract To Hire

Reference: BH-373203

Sr Validation Engineer (NON IT)
Indianapolis, IN- ON SITE
9 month W2 contract (TEMPORARY TO HIRE)
Pay rate: $35-40/hour - Depending on Education and Experience

Summary:
Monday to Friday 8am to 5pm
Intent to convert after 90 days based on performance.
Pharmaceutical experience required

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.

Responsibilities:

• Assess and define assigned validation projects.
• Liaise between engineering and quality assurance throughout validation lifecycle of packaging equipment and data historian network.
• Writing, reviewing, and implementing 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) and conduct trainings
• Partner with quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance

• 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.

• 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.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs