CSV Specialist II

Our wonderful client in the manufacturing industry is looking for a CSV Specialist to join their growing team!

Job Summary :

The CSV Specialist will be responsible for designing, executing, and overseeing computer system validation activities to ensure the reliability and compliance of our manufacturing systems. This role requires a deep understanding of regulatory requirements, attention to detail, and effective communication skills. The candidate must also possess experience in cleaning validation and / or autoclave validation.

Responsibilities :

• Develop and implement validation plans, protocols, and reports for computerized systems, ensuring compliance with regulatory standards.
• Collaborate with cross-functional teams to define validation requirements and specifications.
• Perform risk assessments and impact analyses to identify critical aspects of computerized systems.
• Execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Document and report deviations, ensuring timely resolution.
• Evaluate and assess the impact of changes to computerized systems.
• Implement and manage change control processes to ensure ongoing compliance.
• Maintain accurate and up-to-date documentation for all changes.
• Work closely with internal teams, including IT, Quality Assurance, and Manufacturing, to ensure alignment on validation activities.
• Communicate effectively with external auditors and regulatory agencies during inspections.
• Identify opportunities for process improvements related to CSV activities.
• Perform cleaning validation and autoclave validation activities, ensuring compliance with GMP and FDA guidelines.
• Ensure autoclaves are validated to the required standards, including sterilization cycle validations and ensuring maintenance schedules are followed.
• Stay abreast of industry trends and regulatory updates, ensuring continuous compliance with evolving standards.

Qualifications :

Physical / Mental Requirements :

Our client is an equal-opportunity employer. We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.