Senior Validation Specialist

This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Position Summary: The Senior Validation Specialist serves as a subject 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.

• 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 life cycles.
• 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.

• 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.

• 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.

• 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.

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

Must be US Citizen

• Mid-Senior level

• Full-time

• Science

• Pharmaceutical Manufacturing