CSV Engineer

The CSV Engineer is responsible for planning, executing, and maintaining Computer System Validation (CSV) activities for GxP-regulated computerized systems within pharmaceutical and biotechnology environments. The role involves developing validation documentation (Validation Plans, Risk Assessments, IQ/OQ/PQ, FRS, Configuration Specifications, Data Integrity Assessments, and Validation Summary Reports), ensuring compliance with FDA, EMA, 21 CFR Part 11, and GAMP 5 requirements

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Minimum of 2-5 years of experience in computer system validation or a related field.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
• Experience with validation of various types of systems, including ERP, LIMS, and MES.
• Excellent documentation and technical writing skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Preferred: Certification in Computer System Validation or related areas.
• Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.

Experience need:

• 3+ years of work experience with Computer System Validation
• 3+ years of Biotechnology Research
• experience
• Develop and implement validation strategies for computer systems and software applications.
• Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
• Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
• Conduct validation testing and review test results to ensure systems meet specified requirements.
• Provide training and support to staff on validation processes and procedures.
• Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
• Participate in audits and inspections by regulatory agencies.
• Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, BMS, EMS, & PCS.
• Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
• Assist site Automation groups in configuring I/O and executing CSV protocol requirements.
• Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report