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

• Strong technical writing skills for protocols and SOPs.
• Effective problem-solving and analytical thinking.
• Ability to conduct independent research and justify processes scientifically.
• Proficiency in data analysis and statistical methods.
• Strong computer literacy, including lab software.

Accountabilities

• Accurate application of scientific theory and pharmaceutical methodology.
• Attention to detail and effective communication of technical concepts.
• Ability to identify and resolve compliance or technical issues independently.

Complexity & Technical Requirements

• Knowledge of system configuration, validation, and compliance for computerized systems.
• Familiarity with lab instrumentation and analytical methodologies.
• Ability to manage multiple projects and communicate effectively.
• Advanced computer skills, troubleshooting, and system integration.
• Experience with regulatory expectations, data integrity, and continuous improvement.

Required Knowledge

• Laboratory testing principles for pharmaceuticals
• Pharmaceutical manufacturing processes
• Computerized systems in regulated environments
• cGMPs and post-marketing regulatory requirements

*No H1B visas

*Must be US Citizen

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