Job Description

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.

Job Tags

Similar Jobs