Lead Validation Engineer, GMP Pharma – Onsite (24-Month)

Technical Source; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Technical Source is seeking experienced Validation Engineers/Specialists to support a large-scale pharmaceutical project portfolio at a GMP manufacturing site in the greater Raleigh, NC area. This is a long-term, 24-month contract opportunity across manufacturing, facilities, packaging, laboratory, warehouse, and computerized systems.

The ideal candidate will lead validation activities independently, with hands-on experience validating facility/utilities systems or manufacturing and packaging

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 5+ years of validation experience in GMP-regulated environments.
• Experience authoring and executing validation documentation.
• Strong IQ/OQ/PQ, risk assessments, traceability, deviations, and change controls.
• Experience with GMP requirements and applicable FDA regulations.
• Ability to independently manage validation deliverables across multiple projects.
• Excellent written and verbal communication with cross-functional teams.
• Experience with electronic validation/document management systems preferred.
• On-site work for the duration of the assignment; occasional evenings/weekends.

Responsibilities

• Lead validation activities for assigned pharmaceutical capital and facility projects from requirements development through qualification and, when applicable, decommissioning.
• Develop, revise, and maintain validation documentation including Validation Plans and Reports, User/Functional Requirements, Specifications, Traceability Matrices, and Decommissioning Plans and Reports.
• Author and execute IQ/OQ/PQ and Process Validation activities as required.
• Support commissioning and qualification activities and ensure systems are ready for validation execution.
• Participate in FAT activities as needed.
• Identify, investigate, and document deviations, discrepancies, and engineering changes encountered during validation.
• Initiate, author, and/or support Change Controls and evaluate validation impact.
• Maintain validation documentation and provide regular project status, risk, and escalation updates to Project Managers.
• Participate in recurring project team meetings and lead focused validation meetings as needed.
• Utilize electronic validation and quality systems such as Veeva Vault/QualityDocs and HP ALM/TIMS.
• Ensure validation activities comply with GMP, FDA regulations.

Skills

IQ/OQ/PQ

Risk assessments

Traceability

Deviations

Change controls

Independent project management

Cross-functional collaboration

Strong communication

On-site work

Evening/weekend readiness

Education

Bachelor's degree in Engineering, Life Sciences, or related

Tools

Veeva Vault/QualityDocs

Job description

Technical Source is seeking experienced Validation Engineers/Specialists to support a large-scale pharmaceutical project portfolio at a GMP manufacturing site in the greater Raleigh, NC area. This is a long-term, 24-month contract opportunity across manufacturing, facilities, packaging, laboratory, warehouse, and computerized systems.

The ideal candidate will lead validation activities independently, with hands-on experience validating facility/utilities systems or manufacturing and packaging