CSV Engineer

Deliver Compliance, Quality, and Innovation in Pharmaceutical Manufacturing

Play a critical role in supporting validation activities within a sterile pharmaceutical manufacturing environment in Ireland. This position focuses on ensuring compliance with regulatory requirements, maintaining the validated state of computerized systems, and contributing to continuous improvement initiatives. It is an excellent opportunity for individuals passionate about quality assurance and engineering in the pharmaceutical industry.

Key Responsibilities

• Support the validation of new computerized equipment, automation systems, and control systems.
• Generate and review validation documentation, including protocols and reports.
• Execute and support validation activities such as DQ, IQ, OQ, and PQ.
• Participate in change control processes, providing guidance on Computer System Validation (CSV) requirements.
• Design, implement, and execute validation studies for manufacturing, utility, and control systems.
• Ensure validation activities comply with health, safety, cGMP, environmental, and regulatory requirements.
• Maintain the validated state of computerized systems and equipment through effective lifecycle management.
• Develop, review, execute, and approve validation and revalidation plans.
• Review and approve change controls impacting validated systems.
• Provide technical support regarding FDA, EU GMP, and industry validation requirements.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality, and other departments to ensure compliance and project success.
• Support inspections and audits as required.

Essential Skills and Requirements

• Degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical) or a related discipline.
• Strong understanding of Computer System Validation (CSV) principles and lifecycle management.
• Knowledge of GAMP, ISPE guidance documents, and industry best practices.
• Familiarity with cGMP requirements, pharmaceutical compliance regulations, and quality management systems.
• Experience in validation or computer systems validation roles within healthcare, life sciences, or pharmaceutical manufacturing environments.
• Ability to troubleshoot validation-related issues and implement effective solutions.
• Strong project planning, execution, and stakeholder management skills.
• Effective communication and ability to work both independently and collaboratively within cross-functional teams.
• Self-motivated, adaptable, and results-oriented with strong analytical and problem-solving skills.