Validation Engineer

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

My client is looking for a Validation Engineer II to join their growing team in Raleigh, North Carolina. In this role, you will support validation activities across regulated manufacturing environments, working closely with project teams to deliver compliant validation documentation and execution in line with industry standards.

Reporting directly to the Site Manager, you will collaborate with Project Leaders and cross-functional teams to ensure validation projects are completed efficiently, accurately, and within agreed timelines.

Key Responsibilities

• Develop a strong understanding of validation principles, regulatory requirements, and industry best practices within a GMP-regulated environment.
• Work collaboratively with multidisciplinary project teams to deliver validation activities against project schedules and milestones.

Author and review validation documentation, including:

• URS
• Functional and Design Specifications (FS/DS)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation Summary Reports
• Execute validation protocols and document results while identifying, investigating, and resolving deviations or non-conformances.
• Support change control activities and manage documentation across multiple validation projects.
• Ensure all validation activities comply with internal quality systems and regulatory expectations.

What We’re Looking For

• 1–2 years of validation experience within the pharmaceutical, biotechnology, medical device, or other regulated manufacturing industries.
• 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.
• Exposure to medical device assembly or packaging validation is considered a plus.
• Strong understanding of validation lifecycle and GMP requirements.
• Excellent technical writing and documentation skills.
• High attention to detail and a quality-focused mindset.
• Strong communication and interpersonal skills, with the ability to work effectively alongside clients, contractors, and internal teams.
• Able to manage multiple priorities and work independently or within a collaborative project environment.

If you’re an experienced consultant looking for your next opportunity, apply now for a confidential discussion.