Validation Specialist

Job Title: Validation Specialist – Analytical Instrument Qualification

Location: Clayton, NC (Fully On-site)

Position Summary:

We are seeking a Validation Specialist to support the validation lifecycle of analytical instrument systems and computerized systems within a GxP-regulated environment. The ideal candidate will have hands-on experience with benchtop analytical instruments and a solid understanding of data integrity (DI), SDLC methodologies, and regulatory compliance. This role involves authoring validation documents, managing change controls, and collaborating with cross-functional teams including IT, vendors, and quality assurance.

Key Responsibilities:

Create, author, and support the review of validation lifecycle documents for analytical instrument qualification and computerized systems.

Perform analytical instrument system validation, including systems such as spectroscopy, chromatography, protein analyzers, next-generation sequencers, PCRs, and similar technologies.

Conduct data integrity assessments and verification activities on analytical systems in compliance with regulatory standards.

Prepare and route validation documents for internal review, workflow approval, and submission to Document Control.

Execute approved validation protocols within a GxP facility.

Understand and apply Software Development Life Cycle (SDLC) principles, including Agile methodologies, in project execution.

Collaborate with IT, network teams, vendors, and other stakeholders to ensure timely delivery of validation project deliverables.

Initiate and manage change control processes related to validation projects, ensuring adherence to quality assurance procedures.

Author change control documents for client review and approval.

Qualifications:

Bachelor’s or Master’s degree in a scientific, engineering, or healthcare-related field.

Minimum of 4–5 years of experience in validation, quality assurance, or quality control roles, preferably in the pharmaceutical or life sciences industry.

Prior hands-on experience with benchtop analytical instruments is required.

Strong understanding of data integrity, validation compliance, and GxP requirements.

Familiarity with SDLC processes and methodologies such as Agile.

Excellent documentation and communication skills with attention to detail.