QC - CSV (HPLC/GC)

Role Overview We are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment. Key Responsibilities Lead CSV activities for analytical equipment or instruments and lab computerized systems (e.g., HPLC, GC, UV, LIMS, Empower). Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ protocols, and reports. Ensure compliance with regulatory requirements, industry standards, and company policies. Collaborate with cross-functional teams to identify and prioritize CSV projects. Coordinate with vendors and suppliers for equipment installation, testing, and validation. Perform audits and inspections of laboratory operations to ensure compliance with GMPs and CSV procedures. Develop and maintain documentation, including SOPs, URSs, and test plans. Provide training and support to laboratory personnel on CSV procedures and best practices. Key Requirements Bachelor's degree in a relevant field (e.g., chemical engineering, biochemistry). 5+ years of experience in QC or related field. Strong understanding of computer system validation principles and regulations. Experience with analytical instruments (HPLC, GC, UV) and lab computerized systems (LIMS, Empower). Knowledge of data integrity and global validation standards. Excellent communication and collaboration skills. Ability to work independently and prioritize tasks effectively. Benefits Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and dynamic work environment.