Senior IT Validation Specialist (Pharma / GxP)

Job Description

Job Description

Location:

RTP Area, North Carolina (100% Onsite)

Employment Type:

Full-time, Contract (Long-term assignment, 24+ months for the right candidate)

About the Role:

We are seeking an experienced IT Validation Specialist to support large-scale pharmaceutical manufacturing projects in the RTP area.
The ideal candidate has a strong background in Computer System Validation (CSV) and GxP compliance , with the ability to independently author, execute, and manage validation documentation in a regulated environment.

You will be responsible for ensuring systems are validated in accordance with FDA 21 CFR Part 11 , internal SOPs, and global data-integrity requirements.

Key Responsibilities:

• Develop, execute, and maintain validation documentation (validation plans, IQ/OQ/PQ protocols, reports, decommissioning plans, etc.)
• Participate in change control and risk assessments related to computerized systems
• Support investigations of validation deviations and implement effective corrective actions
• Ensure data integrity and compliance throughout system lifecycle
• Maintain traceability and documentation tracking in alignment with corporate and regulatory standards
• Collaborate with cross-functional teams (IT, Automation, Engineering, QA) to support project deliverables
• Support audits and regulatory inspections as a subject-matter expert in validation

Qualifications:

• Bachelor’s degree in Engineering, Computer Science , or a related technical field
• 5+ years of hands-on experience in Computer System Validation within a GxP-regulated pharmaceutical or biotech environment
• Strong understanding of FDA, EMA, and GAMP 5 guidelines
• Experience with system commissioning, decommissioning, and lifecycle management
• Ability to create validation documentation without supervision
• Excellent communication and documentation skills
• Experience working with fill/finish or process automation systems is preferred

Ideal Candidate:

• Works well in a fast-paced, compliance-driven environment
• Detail-oriented with a strong sense of ownership and accountability
• Able to balance multiple validation projects simultaneously
• Brings a proactive, solutions-oriented mindset

Work Environment:

• Onsite, Monday–Friday (standard business hours)
• Collaborative, professional, and compliance-focused project team
• Long-term engagement with opportunity for extension based on performance

To apply:
Submit your resume highlighting your IT validation , CSV , and pharma compliance experience.
Only candidates with prior pharmaceutical or biotech experience will be considered.

**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.