IT & Automation Validation Lead - Pharma CQV

BaryCon INC.; Clayton (NC); On-site; USD 80,000 - 105,000; Full time

Job summary

BaryCon is seeking a Validation Area Specialist to lead validation activities for IT and automation at our pharmaceutical manufacturing site in Clayton, North Carolina. The role covers planning through execution, investigation, reporting, and transition to validated state, ensuring compliance with GMP and regulatory expectations.

This is a full-time, 12-month onsite assignment starting November 2, 2026, with 8 am to 5 pm hours and a compensation range of $80,000 to $105,000 plus benefits, based

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Minimum seven years of validation or quality experience in a pharmaceutical environment.
• Experience with 21 CFR Part 11, GAMP 5, FDA and ICH guidance, electronic records, and configuration-item management.
• Demonstrated leadership, project-management, stakeholder communication, and technical-writing capabilities.
• Strong knowledge of GMP concepts, procedures, change management, and maintenance of the validated state.

Responsibilities

• Prepare, execute, analyze, and report Installations Verification, Operational Verification, and Performance Validation protocols.
• Own change requests associated with project validation responsibilities.
• Perform compliance and technical reviews of protocols, test data, and supporting documentation.
• Author project quality master plans, validation plans, specifications, procedures, and other key validation documents.
• Lead validation failure investigations and non-conformities using structured root-cause analysis.
• Participate in FAT, SAT, commissioning, and equipment or automation system transition activities.

Skills

Leadership

Project management

Stakeholder communication

Technical writing

Validation expertise

GMP knowledge

Change management

Education

Bachelor's degree in Engineering or related field

Tools

21 CFR Part 11

GAMP 5

Electronic records management

Configuration-item management

FAT/SAT/Commissioning

Job description

BaryCon is seeking a Validation Area Specialist to lead validation activities for IT and automation at our pharmaceutical manufacturing site in Clayton, North Carolina. The role covers planning through execution, investigation, reporting, and transition to validated state, ensuring compliance with GMP and regulatory expectations.

This is a full-time, 12-month onsite assignment starting November 2, 2026, with 8 am to 5 pm hours and a compensation range of $80,000 to $105,000 plus benefits, based