Senior C&Q Engineer

United Pharma; Arizona; On-site; USD 100,000 - 180,000; Full time

Job summary

United Pharma is seeking an experienced Senior Commissioning & Qualification (C&Q) Engineer to support the startup of a newly acquired GMP manufacturing facility. You will focus on commissioning, qualification, equipment and utility systems, facility startup, documentation, troubleshooting, and deviation management.

Key responsibilities include executing C&Q activities for GMP facilities and utilities, developing and reviewing qualification protocols, supporting FAT/SAT activities, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 10+ years of C&Q, Commissioning, Qualification, or Validation experience in Pharma, Biotech, or Life Sciences.
• Experience with IQ/OQ/PQ, commissioning, startup, FAT, and SAT.
• Strong knowledge of GMP/GxP requirements and qualification practices.
• Experience authoring and executing qualification protocols and reports.
• Experience with deviations, investigations, CAPA, and remediation.

Responsibilities

• Execute commissioning and qualification activities for GMP facilities, utilities, equipment, and manufacturing systems.
• Develop, review, and execute commissioning and qualification protocols and test scripts.
• Support FAT, SAT, commissioning, startup, IQ, OQ, and PQ.
• Qualify critical GMP utilities including HVAC, WFI, clean steam, compressed gases, and process utilities.
• Review URS, specifications, P&IDs, drawings, equipment documentation, and vendor packages.
• Coordinate with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and vendors.

Skills

Commissioning

Qualification

Validation

GxP

CAPA

Deviation management

Documentation

Troubleshooting

FAT/SAT

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Job description

We are seeking an experienced Senior Commissioning & Qualification (C&Q) Engineer to support the startup of a newly acquired GMP manufacturing facility. The role will focus on commissioning, qualification, equipment and utility systems, facility startup, documentation, troubleshooting, and deviation management.

Key Responsibilities:

• Execute commissioning and qualification activities for GMP facilities, utilities, equipment, and manufacturing systems.
• Develop, review, and execute commissioning and qualification protocols and test scripts.
• Support FAT, SAT, commissioning, startup, IQ, OQ, and PQ activities.
• Qualify critical GMP utilities including HVAC, WFI, clean steam, compressed gases, and process utilities.
• Support equipment qualification for manufacturing and process equipment.
• Review URS, specifications, P&IDs, drawings, equipment documentation, and vendor packages.
• Perform field verification, functional testing, troubleshooting, and system walkdowns.
• Identify, document, and resolve qualification issues and system deficiencies.
• Lead and support deviations, investigations, CAPA, and remediation activities.
• Prepare and review qualification reports, summary reports, traceability documentation, and other C&Q deliverables.
• Coordinate with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and vendors.
• Ensure C&Q activities comply with GMP, GxP, FDA, and company procedures.
• Support facility startup, manufacturing readiness, and project execution activities.
• Track qualification progress, issues, and deliverables to support project schedules.

Skills & Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 10+ years of C&Q, Commissioning, Qualification, or Validation experience in Pharma, Biotech, or Life Sciences.
• Strong hands‑on experience with facility, utility, and equipment qualification.
• Experience with IQ/OQ/PQ, commissioning, startup, FAT, and SAT.
• Strong knowledge of GMP/GxP requirements and qualification practices.
• Experience authoring and executing qualification protocols and reports.
• Experience with deviations, investigations, CAPA, and remediation.
• Ability to read and interpret P&IDs, specifications, drawings, and equipment documentation.
• Strong troubleshooting, problem‑solving, and technical documentation skills.
• Experience working in fast‑paced facility startup, construction, or buildout projects.
• Strong communication and cross‑functional collaboration skills.