Indianapolis, Indiana, 46241
Job description
Validation Engineer – Facilities
Location: Indianapolis, IN
Compensation: $80,000 – $95,000
The Validation Engineer will play a vital role in supporting Commissioning, Qualification, and Validation (CQV) functions for facilities, utilities, and process systems within the Pharmaceutical and Life Sciences sectors. This position is essential to ensuring that crucial systems—such as HVAC, clean utilities, process utilities, and controlled environments—comply with Good Manufacturing Practices (GMP), safety regulations, and quality standards. The successful candidate will possess practical experience in facility and utility qualification and will have a strong foundation in technical, communication, and organizational skills within regulated settings.
Key Responsibilities:
- Perform Commissioning, Qualification, and Validation (CQV) tasks related to facilities, HVAC systems, cleanrooms, and various utility systems (including WFI, PW, compressed air, process gases, and clean steam).
- Ensure that C&Q activities are completed on time and adhere to project plans, safety protocols, and GMP standards.
- Create and update CQV documentation, such as User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, and Validation Master Plans (VMPs).
- Assist with system walkdowns, design assessments, and resolution of punch list items concerning utilities and building systems.
- Lead and contribute to FATs, SATs, equipment shakedown, and qualification testing processes.
- Work collaboratively with engineering, maintenance, and QA teams to ensure seamless integration of new systems into existing operations.
- Maintain validation packages to meet both regulatory and client standards, ensuring audit readiness at all times.
- Plan for necessary commissioning consumables, calibration standards, and resources required for the execution of qualifications.
- Coordinate vendor and contractor tasks related to HVAC balancing, cleanroom certification, and utility validation.
- Detect and address performance or compliance issues within systems, proposing corrective measures when needed.
Requirements for the Validation Engineer:
- Bachelor’s degree in Engineering (Mechanical, Chemical, or a related field), Life Sciences, or comparable professional experience.
- A minimum of 2 years of experience in validation of facilities or utilities in the Pharmaceutical or Life Sciences sectors.
- Solid knowledge of GMP, FDA, and EU regulatory requirements pertaining to controlled environments and utility systems.
- Experience with commissioning and qualifying HVAC systems, cleanrooms, WFI/PW systems, clean steam, and compressed air systems.
- Skilled in interpreting P&IDs, design plans, and equipment specifications.
- Exceptional written and oral communication abilities, adept at customizing technical information for various audiences.
- Strong analytical, organizational, and documentation capabilities.
- A proactive approach, demonstrating integrity and dedication to continuous improvement practices.
- Readiness to travel domestically and, on occasion, internationally, as necessary for project requirements.
