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Validation Engineer Requirements:
Facilities Validation Engineer
Indianapolis
, IN Direct Hire
Hybrid
Validation Engineer – Facilities
Indianapolis, IN
$80-95,000
The Validation Engineer will support Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, and process systems within the Pharmaceutical and Life Sciences industries. This role plays a key part in ensuring critical systems—including HVAC, clean utilities, process utilities, and controlled environments—meet GMP, safety, and quality requirements. The ideal candidate will have hands-on experience with facility and utility qualification and possess strong technical, communication, and organizational skills in regulated environments.
Validation Engineer Responsibilities:
- Execute Commissioning, Qualification, and Validation (CQV) tasks for facilities, HVAC systems, cleanrooms, and utility systems (e.g., WFI, PW, compressed air, process gases, and clean steam).
- Deliver C&Q activities on schedule and in compliance with project plans, safety standards, and GMP requirements.
- Develop and maintain CQV documentation including User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, and Validation Master Plans (VMPs).
- Support system walkdowns, design reviews, and punch list resolution for utilities and building systems.
- Lead and participate in FATs, SATs, equipment shakedown, and qualification testing.
- Collaborate with engineering, maintenance, and QA teams to ensure proper integration of new systems into ongoing operations.
- Ensure validation packages meet regulatory and client expectations, maintaining audit readiness at all times.
- Plan for commissioning consumables, calibration standards, and other resources necessary for qualification execution.
- Coordinate vendor and contractor activities related to HVAC balancing, cleanroom certification, and utility validation.
- Identify and troubleshoot system performance or compliance issues, recommending corrective actions.
Validation Engineer Requirements:
- Bachelor’s degree in Engineering (Mechanical, Chemical, or related field), Life Sciences, or equivalent professional experience.
- Minimum of 2 years of experience in facilities or utilities validation within the Pharmaceutical or Life Sciences industry.
- Strong understanding of GMP, FDA, and EU regulatory requirements for controlled environments and utility systems.
- Experience with commissioning and qualification of HVAC, cleanrooms, WFI/PW systems, clean steam, and compressed air systems.
- Proficient in interpreting P&IDs, design drawings, and equipment specifications.
- Excellent written and verbal communication skills, with the ability to tailor technical content to diverse audiences.
- Strong problem-solving, organizational, and documentation skills.
- Demonstrates initiative, integrity, and a commitment to continuous improvement.
- Willingness to travel domestically (and occasionally internationally) as required by project needs
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