Senior CQV Validation Engineer – GMP/Pharma Systems

Katalyst CRO; Rockford (IL); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO in Rockford, IL seeks an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation of equipment, systems, software, and manufacturing processes.

The role requires authoring, reviewing, and executing CQV documentation and test protocols in a regulated environment, along with hands-on testing of automated manufacturing or packaging equipment. Strong communication and cross-functional collaboration are essential for success.

Qualifications

• Bachelor's Degree or equivalent experience.
• 5+ years of experience in commissioning, qualification, validation, or related testing activities.
• Strong experience authoring and executing technical CQV documentation and protocols.
• Experience executing test scripts and documenting results.
• Ability to read and understand technical schematics.
• Strong problem-solving, organizational, and attention-to-detail skills.
• Excellent verbal and written communication skills.

Responsibilities

• Author, edit, review, and execute commissioning, qualification, and validation documentation.
• Execute test scripts and accurately document test results and observations.
• Maintain clear, detailed, and GMP-compliant qualification and validation records.
• Complete assigned validation and qualification activities according to project schedules.
• Read and interpret technical schematics and equipment documentation.
• Identify and test photo sensors, verify part numbers, and perform I/O testing on automated manufacturing equipment.
• Support qualification and testing activities for equipment, systems, software, and manufacturing processes.
• Collaborate effectively with project leaders and cross-functional teams.
• Follow GMP and GDP requirements.

Skills

CQV

GMP compliance

Documentation

Test scripts

Schematic reading

Cross-functional teamwork

MS Office

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Katalyst CRO in Rockford, IL seeks an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation of equipment, systems, software, and manufacturing processes.

The role requires authoring, reviewing, and executing CQV documentation and test protocols in a regulated environment, along with hands-on testing of automated manufacturing or packaging equipment. Strong communication and cross-functional collaboration are essential for success.