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Job Summary:

We are seeking a highly experienced Senior CSV Engineer/Analyst to oversee lab system configuration, system integration, and ensure compliance with cGMP and regulatory standards. This role is critical to managing the validation of laboratory and manufacturing systems, ensuring system reliability and regulatory compliance. The ideal candidate will have a strong background in laboratory systems such as HPLC, LIMS , and chromatography workflows . In addition to managing validation projects, you will conduct root cause analysis, collaborate with cross-functional teams, and provide technical guidance to ensure process improvements and compliance with all industry standards.

Key Responsibilities:

• Lead the validation of laboratory systems and manufacturing processes, ensuring compliance with cGMP standards and regulatory requirements.
• Manage the validation lifecycle, including the preparation and execution of validation plans, protocols, test scripts, and summary reports.
• Oversee system configuration and integration for laboratory systems such as HPLC , LIMS , and chromatography workflows.
• Conduct and document root cause analysis for system issues and deviations, implementing corrective actions as needed.
• Collaborate with cross-functional teams, including Quality Assurance, IT, and Operations, to ensure validation activities are aligned with business goals.
• Ensure all documentation adheres to Good Documentation Practices (GDP) and regulatory standards, including GMP guidelines.
• Provide technical expertise and guidance in CQV (Commissioning, Qualification, and Validation) activities for process equipment.
• Stay up-to-date with industry regulations and trends to ensure compliance with evolving standards and best practices.
• Perform periodic reviews and revalidation of systems as required by regulatory and internal standards.
• Support audits and inspections by regulatory agencies, providing detailed validation documentation and ensuring audit readiness.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• 6+ years of experience in Computer System Validation (CSV) within the pharmaceutical, biotech, or manufacturing sectors.
• Proven experience with laboratory systems such as HPLC , LIMS , and chromatography workflows.
• Strong understanding of GMP , GDP , and regulatory compliance standards (e.g., FDA, EMA).
• Experience with CQV activities for process equipment, including validation of automated systems.
• Strong communication, problem-solving, and time management skills.
• Ability to lead and manage complex projects and work collaboratively with cross-functional teams.
• Proficiency in technical writing and the preparation of validation documents, protocols, and reports.

Skills:

• Expertise in Computer System Validation (CSV) and system integration within regulated environments.
• Strong knowledge of GMP and Good Documentation Practices (GDP) .
• Experience in conducting root cause analysis and implementing corrective and preventive actions (CAPA).
• Familiarity with regulatory requirements for pharmaceutical and biotech industries, including FDA and EMA guidelines.
• Proficient in laboratory systems such as HPLC , LIMS , and chromatography workflows.
• Strong organizational skills with the ability to manage multiple projects simultaneously.