CSV Engineer

CSV Engineer Job Title: CSV Engineer Location: Carmel, IN Duration: 12 Months (potential extension) Position Summary The CSV Engineer is responsible for the qualification and validation of laboratory analytical instruments and associated computer systems within a regulated biotechnology or pharmaceutical environment. This role supports the full instrument lifecycle, including software installation, configuration, validation documentation, compliance activities, and ongoing system support in accordance with regulatory and quality requirements. Key Responsibilities Execute Computer System Validation (CSV) activities and laboratory instrument qualification Author, review, and maintain validation documentation, including protocols and reports Support system administration tasks such as user access management, system upgrades, and configuration control Perform compliance activities, including periodic reviews and audit trail reviews Configure and, when required, install software associated with laboratory instruments Provide technical support throughout the instrument lifecycle, including defining IT infrastructure requirements such as data backup and recovery strategies Develop and maintain standard operating procedures (SOPs) for equipment operation and system use Collaborate with cross-functional teams and external vendors to address validation and compliance requirements Participate in data integrity initiatives related to computer systems and secure desktop installation and configuration Required Qualifications Minimum of 5 years of experience in Computer System Validation (CSV) for laboratory analytical instruments Strong knowledge of 21 CFR Part 11 and experience working in a GMP-regulated laboratory environment Familiarity with compliance and quality systems tools such as GMARS, TrackWise, and Kneat Excellent written and verbal communication skills Strong interpersonal skills with the ability to work effectively across teams Highly organized with strong attention to detail and accuracy Education Bachelor’s degree in Biology, Chemistry, Engineering, Computer Science, or a related scientific or technical discipline Seniority Level Mid-Senior level Employment Type Contract Job Function Science and Engineering Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Biotechnology Research Referrals increase your chances of interviewing at Novozen Healthcare LLC by 2x #J-18808-Ljbffr