Validation Engineer (On-site in Indianapolis)

Turner & Townsend•Indianapolis, IN
•Onsite

About The Position

The Validation Engineer leads, coordinates, and executes validation activities in compliance with current Good Manufacturing Practices (cGMP), corporate quality systems, and applicable regulatory requirements. The role works closely with Quality Assurance, Engineering, Manufacturing, Facilities, and Automation, supporting manufacturing, facilities, utilities, equipment, and computerized systems. It ensures compliance with FDA and global cGMP requirements and data integrity principles (ALCOA+), and owns change controls, protocols, testing execution, reporting, and risk assessments. As a commissioning consultant within the Building Consultancy function, the role assists project teams in delivering building commissioning services. It develops and maintains detailed commissioning schedules and plans, covering pre-commissioning and startup through handover. Responsibilities include overseeing commissioning of building systems, reviewing construction documents and deliverables, writing testing procedures, conducting site observations and testing, and facilitating operations and maintenance staff training. The role is on-site at a client campus three to four days per week; on-site requirements may change based on client needs.

Requirements

  • Bachelor's degree preferred; a combination of experience and education may be considered in lieu of a degree.
  • 5–8 years of relevant experience.
  • Ability to exercise judgment based on analysis of multiple sources of information.
  • Willingness to take a new perspective on existing solutions.
  • In-depth knowledge of Microsoft Office products, such as Word, Excel, and Outlook.
  • Organizational skills and an advanced inquisitive mindset.

Responsibilities

  • Lead, coordinate, and execute validation activities in compliance with cGMP, corporate quality systems, and applicable regulatory requirements.
  • Support manufacturing, facilities, utilities, equipment, and computerized systems.
  • Ensure commissioning and validation activities comply with FDA and global cGMP requirements and data integrity principles (ALCOA+).
  • Own and develop change controls, protocols, testing execution, reporting, and risk assessments.
  • Assist project teams in delivering building commissioning services and develop and maintain detailed commissioning schedules and plans.
  • Cover pre-commissioning and startup phases through handover.
  • Oversee commissioning of HVAC, plumbing, electrical, controls, Building Management Systems (BMS), and low-voltage building systems.
  • Review construction-related design documents, designs, submittals, specifications, and O&Ms for approval.
  • Write custom checklists and detailed testing procedures.
  • Deliver building commissioning services for projects of varying sizes.
  • Review and develop construction project-related reports and deliverable documentation for review and approval.
  • Perform on-site observations, inspections, testing, validation, and verification of building systems.
  • Facilitate O&M staff training sessions.
  • Apply standard principles and techniques to complex assignments and provide innovative solutions.
  • Coach others and share knowledge of the job discipline and related disciplines.
  • Lead by example and model behaviors consistent with CBRE RISE values.
  • Build consensus and persuade others to reach agreement.
  • Explain difficult or sensitive information and work within broad guidelines and policies.

Benefits

  • Flexible working environment that supports work-life balance
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