Senior CQV Engineer: Commissioning & Validation Lead

Katalyst CRO; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Bloomington, IN seeks an experienced CQV/Engineering professional to support implementation, modification, commissioning, and qualification of manufacturing equipment and systems.

You will review drawings, coordinate with vendors and cross-functional teams, author CQV documentation, and provide hands-on field support during installation, startup, testing, and qualification in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or related discipline preferred or equivalent experience.
• 5+ years supporting engineering, commissioning, qualification, validation, or equipment implementation in regulated environments.
• Strong understanding of manufacturing equipment design, installation, operation, testing, and maintenance.
• CQV lifecycle experience: FAT, SAT, IQ/OQ/PQ.
• Ability to read engineering drawings and technical documentation.
• Proven communication and project coordination skills.
• Onsite work in Bloomington, IN.

Responsibilities

• Provide engineering and CQV support for implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
• Review drawings and documentation (P&IDs, datasheets, electrical drawings, vendor docs).
• Coordinate with vendors, engineering, manufacturing, automation, quality, and stakeholders.
• Author, review, and revise CQV engineering documentation (URS, IQ/OQ/PQ, risk assessments, traceability).
• Support field activities during installation, startup, testing, and qualification.

Skills

CQV lifecycle knowledge

Vendor coordination

Documentation writing

Engineering troubleshooting

Education

Bachelor's degree in Engineering or related discipline

Job description

Katalyst CRO in Bloomington, IN seeks an experienced CQV/Engineering professional to support implementation, modification, commissioning, and qualification of manufacturing equipment and systems.

You will review drawings, coordinate with vendors and cross-functional teams, author CQV documentation, and provide hands-on field support during installation, startup, testing, and qualification in a regulated environment.