GMP Validation Engineer II – Documentation & Compliance

CBSbutler; Raleigh (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

CBSbutler seeks a Validation Engineer II to join the Raleigh, NC team. You will support validation activities in GMP-regulated manufacturing environments and work with project teams to deliver compliant validation documentation and execution.

You will author/review URS, FS/DS, OQ/PQ, Validation Summary Reports, and execute protocols while addressing deviations. Strong writing and communication are essential.

Qualifications

• 1–2 years of validation experience in pharmaceutical/biotech/medical device or other regulated environments.
• Experience with Change Control and Deviation Management processes.
• Familiarity with commissioning and qualification documentation IQ/OQ/PQ.
• Experience with Cleaning Validation, Sterilisation Validation or Decontamination Validation is advantageous.

Responsibilities

• Develop a strong understanding of validation principles, regulatory requirements, and GMP within a regulated environment.
• Collaborate with multidisciplinary project teams to meet validation schedules and milestones.
• Author and review validation documentation (URS, FS/DS, OQ, PQ, Validation Summary Reports).
• Execute validation protocols and document results, addressing deviations/non-conformances.
• Support change control activities and manage documentation across projects.
• Ensure validation activities comply with internal QA systems and regulatory expectations.

Skills

Technical writing

Communication skills

Attention to detail

Independent worker

Project collaboration

Job description

CBSbutler seeks a Validation Engineer II to join the Raleigh, NC team. You will support validation activities in GMP-regulated manufacturing environments and work with project teams to deliver compliant validation documentation and execution.

You will author/review URS, FS/DS, OQ/PQ, Validation Summary Reports, and execute protocols while addressing deviations. Strong writing and communication are essential.