Validation Engineer

Job Title: Validation Engineer

Duration: 6-month Contract-to-Hire

Location: Onsite, Castleton, IN, near Castleton Square Mall

Schedule: Monday-Friday, onsite

Must-Haves:

• Bachelor’s degree in Engineering, ideally Mechanical, Electrical, or Biomedical Engineering
• AF&ID experience and ability to review, interpret, and/or edit technical engineering drawings
• HVAC, building automation, controls, or mechanical systems experience
• Hands-on validation, qualification, or commissioning experience
• Experience executing or supporting IQ/OQ/PQ protocols, CQV, CSV, equipment validation, or test-method validation
• Experience working within an FDA-regulated, cGMP, medical device, pharmaceutical, or similarly controlled environment
• Understanding of validation documentation and maintaining systems/equipment in an audit-ready state
• Local to the Indianapolis area and able to work onsite in Castleton Monday-Friday

Plusses:

• Pharmaceutical or medical-device validation experience
• Computer System Validation (CSV) experience
• Experience with CAD, GD&T, or engineering drawing development/revisions
• Experience qualifying or validating equipment, instrumentation, tooling, or manufacturing processes
• Experience working cross-functionally with Quality, Regulatory, Manufacturing, Calibration, and Engineering
• Familiarity with 21 CFR Part 11 / FDA quality requirements
• Experience in environments involving equipment or systems with human-safety considerations

Day-to-Day:

• Execute and support commissioning, qualification, and validation activities for systems supporting an FDA-regulated pharmaceutical environment
• Develop, review, revise, and execute IQ/OQ/PQ and CQV documentation/protocols
• Review and interpret AF&IDs and other engineering drawings as part of validation and commissioning activities
• Verify equipment and systems meet established engineering, quality, and regulatory requirements
• Support validation documentation and ensure systems remain compliant and audit-ready
• Work with Engineering, Quality, Operations, and other technical stakeholders to investigate and remediate validation issues
• Assist with qualification of equipment, instrumentation, controls, and associated systems
• Review test results and supporting documentation to confirm acceptance criteria have been satisfied

Job Description:

Insight Global is seeking a Validation Engineer for a top building automation/HVAC client supporting a major pharmaceutical customer. This engineer will be responsible for commissioning, qualification, and validation activities within an FDA-regulated environment, including the execution and documentation of CQV and IQ/OQ/PQ protocols. The ideal candidate will come from a hands-on validation background and be comfortable reviewing AF&IDs and engineering drawings, working with mechanical/electrical equipment, and partnering cross-functionally to ensure systems meet engineering and regulatory requirements. Candidates do not need to come directly from pharmaceutical manufacturing, but they should have experience working in a regulated environment and a strong interest in growing within the validation space.

Compensation:

$35/hr to $55/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.