CSV Engineer

• Collaborate with IT, Quality Assurance, and Operations to ensure compliance with regulatory guidelines and internal policies.
• Work with vendors and suppliers to meet validation requirements for third-party systems.
• Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
• Create and maintain validation documentation, including validation plans, test scripts, traceability matrices, and validation summary reports.
• Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
• Participate in change control processes, assessing system changes and executing appropriate validation activities.
• Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
• Stay current with industry trends, regulatory updates, and advancements in computer system validation practices.
• Support regulatory inspections and audits by providing documentation and participating in discussions related to computer system validation.

• Bachelor's degree in Computer Science, Engineering, or a related field.

• 5+ years of experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.

• Experience with sterile drug product manufacturing and associated equipment, utilities, laboratory instruments, and IT infrastructure enterprise systems.

• Experienced in computer systems validation (CSV) from requirements through release of SCADA/PLC-controlled equipment (e.g., filling lines, isolators, lyophilizers).

• Experienced in computer systems validation (CSV) of Emerson DeltaV.

• Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

• Understanding of data integrity principles and practices.

• Completion of Electronic Records/Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment and utility systems.

• Familiarity with validation methodologies, including risk-based validation approaches.

• Proficiency in creating and executing validation protocols and documenting validation activities.

• Knowledge of software development life cycle (SDLC) and change control processes.

• Experienced in the use of paperless validation and test tools, such as ValGenesis, Kneat, and ALM.

• Excellent analytical and problem-solving skills, with strong attention to detail.

• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.

• Ability to work independently and manage multiple projects simultaneously.

Next Generation