CSV Engineer

Proclinical; Waterford; On-site; EUR 60,000 - 90,000; Full time

Job summary

Proclinical is seeking a CSV Engineer to support validation activities within a sterile pharmaceutical manufacturing environment in Ireland. You will ensure regulatory compliance, maintain validated state of computerized systems, and contribute to continuous improvement initiatives.

Responsibilities include validation of equipment and control systems, creating protocols and reports, executing DQ/IQ/OQ/PQ, and supporting change controls with cross-functional collaboration to ensure project

Qualifications

• Degree in Science or Engineering or related discipline.
• Strong understanding of CSV principles and lifecycle management.
• Familiarity with GAMP, ISPE guidance documents, and industry best practices.
• Experience in validation roles within healthcare, life sciences, or pharmaceutical manufacturing environments.

Responsibilities

• Support 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 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 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-functional with Manufacturing, Engineering, Quality, and other departments.

Skills

CSV principles

Lifecycle management

GAMP

ISPE guidelines

cGMP

Quality management

Education

Science or Engineering degree

Job description

Ready to play a critical role in delivering compliance, quality, and innovation within a leading pharmaceutical manufacturing facility in Ireland?

Proclinical is seeking a CSV Engineer to support validation activities within a sterile pharmaceutical manufacturing environment in Ireland. In this role, you will ensure compliance with regulatory requirements, maintain the validated state of computerized systems, and contribute to continuous improvement initiatives. This is an excellent opportunity for individuals passionate about quality assurance and engineering in the pharmaceutical industry.

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-functional with Manufacturing, Engineering, Quality, and other departments to ensure compliance and project success.
• Support inspections and audits as required.

Key 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.