Job Description

Our client is seeking experienced Validation Engineers/Validation 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 supporting multiple projects across manufacturing, facilities, packaging, laboratory, warehouse, and computerized systems.

The ideal candidate will have strong pharmaceutical validation experience and be capable of independently leading validation activities with minimal guidance. Candidates with hands-on experience validating facility/utilities systems or manufacturing and packaging equipment are especially encouraged to apply.

Key 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
• Risk Assessments
• Traceability Matrices
• Decommissioning Plans and Reports
• Author and execute Design Reviews, DQ, 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, EU Annex 15, GAMP 5, and applicable company procedures.

Preferred Project Experience

Our client is particularly interested in candidates with validation experience in one or more of the following areas:

Facilities & Utilities

• HVAC and environmental systems
• Building Management Systems (BMS)
• Facility utility systems
• Refrigeration
• Process instrumentation and monitoring systems
• Electrical distribution, switchgear, and controls
• GMP facility modifications and laboratory environments

Manufacturing & Packaging Systems

• Pharmaceutical manufacturing equipment
• Aseptic formulation and filling equipment
• RABS (Restricted Access Barrier Systems)
• Vision inspection systems
• Packaging equipment and production line modifications
• Medical device assembly equipment
• Manufacturing equipment upgrades and modifications

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred.
• 5+ years of validation experience within a pharmaceutical, biotech, medical device, or other GMP-regulated environment.
• Demonstrated experience authoring and executing validation documentation.
• Strong understanding of IQ/OQ/PQ, risk assessments, traceability, deviations, and change controls .
• Experience working with GMP requirements and applicable FDA regulations.
• Ability to independently manage validation deliverables across multiple projects.
• Strong written and verbal communication skills with the ability to work effectively with Project Managers, Engineering, Quality, Operations, and other cross-functional teams.
• Experience with electronic validation/document management systems is preferred.
• Must be comfortable working on-site for the duration of the assignment.
• Ability to support occasional evening or weekend work during major project activities or plant shutdowns.

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