Validation Area Specialist IT Automation

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

Job Description

Job Description

Validation Area Specialist - IT & Automation

Reference: JQRI26SEP001

BaryCon is seeking a Validation Area Specialist to lead validation services supporting IT and automation projects at a pharmaceutical manufacturing site in Clayton, North Carolina. The role owns validation deliverables from planning through execution, investigation, reporting, and transition to the validated state.

ASSIGNMENT DETAILS

Full-time contract assignment; 100% onsite in Clayton, NC.

Monday-Friday, 8:00 AM-5:00 PM.

Anticipated start: November 2, 2026.

Duration: 12 months, with possible extension based on performance.

Annual compensation: $80,000-$105,000 plus benefits, based on experience and engagement structure.

Overtime: pre-approved only; paid at the agreed straight-time rate.

No per diem; local candidates preferred; 0% planned travel.

Background check and client onboarding required.

KEY RESPONSIBILITIES

• Prepare, execute, analyze, and report Installation 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.

REQUIRED QUALIFICATIONS

• Bachelor's degree in Engineering, Computer Science, or another applicable technical discipline, or equivalent relevant experience.
• 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.

TECHNICAL FOCUS

IT and automation validation for direct-impact systems and processes; IV, OV and PV protocols; validation and quality master plans; specifications; CILs; deviations; change controls; FAT/SAT and commissioning support; root-cause analysis and validation process improvement.

WORK ENVIRONMENT

Work may include movement of equipment or supplies up to approximately 33 pounds, close-precision work, occasional ladder use, elevated work, and work around controlled or potentially hazardous materials, subject to site safety requirements.

ABOUT BARYCON

BaryCon supports leading pharmaceutical companies with engineering oversight, project management, CQV execution, validation, BIM/VDC services, and technical consulting across the U.S. and Europe.

Company Description

BaryCon is a leading Global provider of professional engineering and project management services, specializing in the construction and pharmaceutical industries. We focus on delivering innovative, high-quality solutions for our clients while fostering a collaborative and supportive work environment. With a commitment to integrity, safety, and growth, BaryCon offers employees opportunities to advance their careers within a rapidly expanding organization.

Company Description

BaryCon is a leading Global provider of professional engineering and project management services, specializing in the construction and pharmaceutical industries. We focus on delivering innovative, high-quality solutions for our clients while fostering a collaborative and supportive work environment. With a commitment to integrity, safety, and growth, BaryCon offers employees opportunities to advance their careers within a rapidly expanding organization.