Ready to play a critical role in delivering compliance, quality, and innovation within a leading pharmaceutical manufacturing facility in Ireland?
̽»¨ºÏ¼¯ 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.
If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at n.sudsok@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy
