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C&Q Engineer

Indianapolis 70,000 - 90,000 / YR Permanent

Job Responsibilities

  • Develop and execute Commissioning & Qualification (C&Q) protocols with minimal supervision.
  • Take ownership of assigned systems, equipment, and project deliverables.
  • Perform commissioning, qualification, and validation activities in compliance with project requirements.
  • Document test results, deviations, investigations, and corrective actions accurately.
  • Prepare and maintain validation documentation including risk assessments, test plans, protocols, and summary reports.
  • Review and provide feedback on technical documentation prepared by junior engineers.
  • Ensure all documentation is compliant, audit-ready, and aligned with regulatory standards.
  • Coordinate C&Q activities with clients, vendors, contractors, and cross-functional project teams.
  • Support project scheduling, resource planning, progress tracking, and status reporting.
  • Identify project risks and proactively escalate issues while recommending solutions.
  • Apply risk-based verification methodologies and industry best practices such as ASTM E2500 and ISPE guidelines.
  • Ensure compliance with GMP, FDA, and other applicable regulatory requirements.
  • Participate in and support internal audits, client audits, and regulatory inspections.
  • Mentor and provide technical guidance to junior engineers and team members.
  • Support knowledge transfer initiatives and contribute to team training efforts.
  • Serve as a technical resource for commissioning, qualification, and validation activities.
  • Manage multiple priorities and project timelines while maintaining quality standards.

Qualifications

  • Bachelor's degree in Engineering or a related technical discipline.
  • 2–5 years of experience in commissioning, qualification, validation, or related engineering functions.
  • Experience within pharmaceutical, biotechnology, chemical, life sciences, or regulated manufacturing environments.
  • Demonstrated ability to independently manage assigned systems, equipment, or project scope.
  • Knowledge of GMP regulations and FDA compliance requirements.
  • Familiarity with industry standards and guidelines including ASTM E2500 and ISPE.
  • Experience developing and executing validation and qualification documentation.
  • Strong technical writing, documentation, and organizational skills.
  • Ability to troubleshoot technical issues and implement effective solutions.
  • Excellent communication and interpersonal skills with the ability to work effectively with clients, vendors, and cross-functional teams.
  • Strong project coordination and time-management abilities.
  • Experience using validation, quality, or project management tools such as Kneat and Smartsheet preferred.
  • Ability to mentor junior engineers and contribute to team development.
  • Ability to work on-site and support project execution activities in a regulated manufacturing environment.
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