Commissioning & Qualification (C&Q) Engineer

Position Overview

We are seeking experienced Commissioning & Qualification (C&Q) Engineers to support the commissioning and startup of a pharmaceutical manufacturing facility in Manhattan, KS. This role requires hands-on expertise in commissioning processes, temperature monitoring systems, and critical utilities within a regulated environment.

This is a fast-paced opportunity with an expedited interview process and immediate onboarding for qualified candidates.

Key Responsibilities

• Execute commissioning and qualification activities for facility systems and process equipment
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
• Support startup, testing, and validation of systems including HVAC, clean utilities, and temperature monitoring systems (TMS)
• Review, execute, and document commissioning protocols, test scripts, and reports
• Identify and troubleshoot system issues during commissioning and startup phases
• Ensure all activities comply with GMP (Good Manufacturing Practices) and regulatory requirements
• Collaborate with cross-functional teams including Engineering, Quality Assurance, Validation, and Operations
• Maintain accurate and compliant documentation for all commissioning activities
• Support deviation investigations, root cause analysis, and CAPA implementation during commissioning
• Assist in ensuring systems are audit-ready and meet regulatory inspection standards

Required Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical Engineering, or a related discipline
• 4–10 years of experience in commissioning and qualification within regulated industries
• Hands-on experience with:
• Commissioning of pharmaceutical, biotech, or industrial facilities
• Temperature Monitoring Systems (TMS)
• HVAC systems and critical utilities (e.g., clean steam, WFI, compressed air)
• Strong knowledge of GMP regulations and compliance requirements
• Ability to read and interpret P&IDs, engineering drawings, and technical documentation
• Proven troubleshooting and problem-solving capabilities in a startup environment
• Strong documentation and communication skills

Preferred Qualifications

• Prior experience commissioning pharmaceutical or life sciences facilities
• Familiarity with validation lifecycle (IQ/OQ/PQ) and documentation practices
• Experience working with Building Management Systems (BMS) / Environmental Monitoring Systems (EMS)
• Exposure to FDA-regulated environments and audit readiness activities