Senior CQV Engineer - GMP Validation Leader

Katalyst-Healthcares-; Columbus (OH); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and manufacturing processes in a regulated environment.

The ideal candidate will author, review, and execute CQV documentation and test protocols, perform hands-on testing of automated manufacturing equipment, and collaborate with cross-functional teams while ensuring GMP/GDP compliance.

Qualifications

• 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.
• Ability to work effectively both independently and as part of a team.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

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 documentation

Test scripting

GMP/GDP knowledge

Read schematics

Problem solving

Team collaboration

MS Word

MS Excel

MS PowerPoint

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Summary :
We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and manufacturing processes. The ideal candidate will have strong experience authoring, reviewing, and executing CQV documentation and test protocols in a regulated environment. This role will also involve hands-on testing of automated manufacturing or packaging equipment.
Roles and 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 Good Documentation Practices (GDP) requirements.

Education and Experience:

• 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.
• Ability to work effectively both independently and as part of a team.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Preferred Qualifications:

• Experience supporting packaging equipment or packaging line qualification and validation.
• Experience in pharmaceutical, medical device, combination product, or other regulated manufacturing environments.