Senior Technical Operations Validation Specialist

Senior Technical Operations Validation Specialist

We are seeking a subject matter expert (SME) for validation across processes, equipment, facilities, cleaning procedures, and computerized systems within the pharmaceutical quality unit. The role supports validation of processes, equipment, facilities, cleaning procedures, and computerized systems; provides commercial and R&D support as needed; ensures computerized systems function as intended and maintains written procedures and practices for data integrity and regulatory compliance.

• Create validation protocols for processes, equipment (IQ, OQ, PQ), cleaning procedures, facilities, and computerized systems.
• Serve as system administrator and technical SME to ensure systems are qualified, compliant with regulatory and corporate data integrity standards, and that lifecycle processes (change control, validation, training, documentation, security, electronic records/electronic signatures, audit trails, data integrity, etc.) are in place.
• Provide primary technical support for QC laboratories for analytical method development, problem-solving, and validation; lead equipment validation (IQ, OQ, PQ).
• Configure and test software such as LIMS, CDS, and other QC computerized systems to maximize functionality.
• Prepare and compile data to analyze test information, diagnose malfunctions, and write technical papers, reports, or standards/specifications for processes, facilities, products, or tests.
• Support risk assessments for product quality inquiries and assist with assessment of emerging risks in the pharmaceutical industry.
• Liaise with laboratory managers, QC personnel, IT, and service providers to resolve questions and provide training.
• Support technical documentation for CMC supplements, Annual Reports, and Annual Product Reviews to aid Quality and Regulatory Affairs with product registrations as needed.
• Assist with evaluation, implementation, and validation of identified software for new applications or replacements.
• Perform ancillary data management tasks and support system interfaces as needed.
• Immediately notify lab personnel of operational challenges or hardware/software issues to enable prompt action.
• Set up/modify product specifications and test methods, run tests in LIMS and SAP as needed per change control tasks.
• Recommend improvements to methods and operations for cGMP compliance, efficiency, cost, and performance.
• Assist with technical writing, e.g., revision of analytical procedures, equipment SOPs, results summaries, drug product registrations, investigations, CAPAs, risk assessments, etc.
• Carry out other duties as needed to meet goals and production plans; stay current with technical literature and training opportunities; promote safety in practice.
• Perform statistical analysis of laboratory and process data to support Annual Product Reviews and Continued Process Verification programs.

• BS/BA in a STEM field; MS or Ph.D. preferred.
• Experience writing validation protocols across pharmaceutical manufacturing (minimum 5 years).
• Experience with database management and computer systems (LIMS or similar) and analytical experience in the pharmaceutical industry preferred.
• Experience with analytical techniques, test methodology, method development, validation, and data integrity in a CGMP/FDA regulated environment.
• Knowledge of pharmaceutical solid oral dosage form manufacturing processes.
• Strong knowledge of current Good Manufacturing Practices.

• Technical writing for validation Protocols, risk assessments, and SOPs in FDA-regulated environments.
• Ability to conduct independent research to justify procedures, processes, or products.
• Data analysis skills, including statistical analysis for SPC and related applications.
• Strong computer skills (word processing, spreadsheets, software applications).

• Accurate scientific methodology and pharmaceutical laboratory practices; attention to detail and problem-solving ability; ability to train and communicate principles clearly.
• Strong interpersonal and leadership skills; effective verbal and written communication.
• Ab…