Senior Validation Specialist

Job Description

Position Summary :

The Senior Validation Specialist serves as a s ubject matter expert (SME) for technical functions within a pharmaceutical quality unit. Responsibilities include validation of processes, equipment, facilities, cleaning procedures, and computerized systems, as well as support for commercial operations and R&D. This role ensures all computerized systems function as intended and comply with regulatory expectations. Additional support includes QC and technical laboratories for analytical method development, troubleshooting, and equipment validation.

Key Responsibilities

• Develop and execute validation protocols (IQ / OQ / PQ) for processes, equipment, cleaning procedures, facilities, and computerized systems.
• Serve as system administrator and SME for qualified systems, ensuring compliance, efficient workflows, and robust data integrity across system lifecycles.
• Provide technical support to QC labs for method development, troubleshooting, and equipment validation.
• Configure and validate lab systems (LIMS, CDS, etc.) for functionality and compliance.
• Analyze test data, prepare technical reports, and establish standards / specifications.
• Support product and process development through research and compound studies.
• Conduct risk assessments for quality inquiries and formulation evaluations.
• Collaborate with QC managers, IT, and service providers to resolve issues and provide training.
• Assist with technical documentation for regulatory submissions (CMC supplements, annual reports).
• Evaluate, implement, and validate new or replacement software applications.
• Manage data and perform interface testing between systems.
• Maintain product specifications and test methods in LIMS and ERP systems (e.g., SAP).
• Recommend and implement process improvements for compliance and efficiency.
• Support technical writing (SOPs, investigation reports, CAPAs, risk assessments).
• Stay current with industry literature, regulations, and training opportunities.
• Perform statistical analysis for annual product reviews and process verification.

Knowledge, Skills & Abilities

Accountabilities

Complexity & Technical Requirements

Required Knowledge