Position: Senior Validation Specialist
Position Summary:
The Senior Validation Specialist serves as a subject matter expert (SME) for various technical functions within the scope of a pharmaceutical quality unit. Responsibilities include validation of processes, equipment, facilities, cleaning procedures, and computerized systems; support for commercial operations and R&D as needed. The specialist ensures all computerized systems function as intended and are compliant with regulatory expectations. This role also provides primary support to QC and technical laboratories, including 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 regulatory compliance, efficient workflows, and robust data integrity practices across system lifecycles (e.g., change control, validation, coding standards, electronic records/signatures, audit trails).
- Provide technical support to QC laboratories for method development, problem-solving, and equipment validation activities.
- Configure and validate laboratory systems such as LIMS, CDS, and other computerized QC tools to maximize functionality and compliance.
- Analyze test data to assess process and equipment efficiency or diagnose issues; prepare technical reports, standards, and specifications.
- Support product and process development through scientific research and compound studies.
- Conduct risk assessments for quality inquiries, formulation evaluations, and emerging industry risks.
- Collaborate with QC managers, IT, and service providers to address issues, provide training, and ensure smooth operations.
- Assist with technical documentation for regulatory submissions (e.g., CMC supplements, annual reports, product reviews).
- Evaluate, implement, and validate new or replacement software applications.
- Manage data and perform interface testing between systems as needed.
- Notify laboratory personnel of system issues and assist with timely resolution.
- Set up and update product specifications, test methods, and calculations in LIMS and ERP systems (e.g., SAP) per approved change control processes.
- Recommend and implement process improvements for compliance, efficiency, and performance.
- Support technical writing tasks (e.g., SOPs, procedures, investigation reports, CAPAs, risk assessments).
- Participate in departmental activities to support business objectives and production goals.
- Stay current with industry literature, regulations, and training opportunities.
- Promote and practice safe laboratory behaviors based on training and safety protocols.
- Perform statistical analysis to support annual product reviews and continued process verification efforts.
Knowledge, Skills & Abilities:
- Strong technical writing skills for protocols, risk assessments, and SOPs.
- Effective problem-solving and analytical thinking capabilities.
- Ability to conduct independent research and justify procedures and processes scientifically.
- Proficiency in data analysis, including statistical methods for trend analysis and process control.
- Strong computer literacy, including spreadsheets, word processing, and specialized lab software.
Accountabilities:
- Accurate and reliable application of scientific theory and pharmaceutical laboratory methodology.
- Strong attention to detail and ability to communicate technical concepts effectively.
- Solid teamwork, leadership, and interpersonal communication skills.
- Capable of identifying and resolving compliance or technical issues and implementing appropriate corrective actions.
- Operates independently with sound decision-making and prioritization in a multi-disciplinary environment.
Complexity & Technical Requirements:
- Knowledge of system configuration, validation, and compliance for computerized systems.
- Familiarity with laboratory instrumentation and analytical methodologies.
- Ability to manage multiple concurrent projects and effectively communicate with internal and external stakeholders.
- Advanced computer skills, including troubleshooting of hardware/software, system optimization, and integration.
- Experience with regulatory expectations, data integrity, statistical tools, root cause analysis, and continuous improvement.
- Ability to evaluate product formulations in the context of quality and risk assessments.
Required Knowledge:
- Laboratory testing principles for pharmaceuticals
- Pharmaceutical manufacturing processes
- Computerized systems in regulated environments
- cGMPs and post-marketing regulatory requirements (e.g., pharmacovigilance)