CSV Engineer

Proclinical; Schweiz; On-site; CHF 65,000 - 84,000; Full time

Job summary

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

Collaborating with Manufacturing, Engineering, and Quality teams, you will design and execute validation studies, review protocols, and support inspections and audits to ensure product quality and patient safety.

Qualifications

• Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering.
• Strong CSV principles and lifecycle knowledge.
• Familiarity with cGMP and regulatory requirements.
• Experience in validation or CSV in pharma/healthcare.
• Ability to troubleshoot validation-related issues.

Responsibilities

• Validate new computerized equipment, automation and control systems.
• Generate and review validation documentation (protocols/reports).
• Execute DQ/IQ/OQ/PQ validation activities.
• Support change controls and CSV requirements.
• Design, implement and execute validation studies for manufacturing, utility and control systems.
• Ensure validation activities comply with health, safety, cGMP and regulatory requirements.
• Maintain the validated state of computerized systems through lifecycle management.
• Develop, review, execute and approve validation/revalidation plans.
• Review and approve change controls impacting validated systems.
• Provide technical support on FDA, EU GMP and validation requirements.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality and others.
• Support inspections and audits as required.

Skills

CSV fundamentals

Lifecycle management

GAMP/ISPE guidance

cGMP knowledge

Validation in pharma

Project management

Cross-functional collaboration

Analytical problem solving

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-functionally 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.