Senior CSV Engineer | Quality Assurance | Ireland

Are you a highly skilled and detail-oriented professional with a passion for ensuring product quality and regulatory compliance? We are seeking a talented Senior CSV Engineer to join our dynamic team in Ireland.

As a Senior CSV Engineer, you will play a critical role in maintaining the highest quality standards for our biopharmaceutical products. You will collaborate closely with cross-functional teams to develop and implement robust quality assurance systems, ensuring adherence to stringent regulatory requirements.

Key Responsibilities:

• Develop, implement, and maintain comprehensive quality assurance procedures, policies, and systems aligned with cGMP and other regulatory frameworks.
• Conduct thorough self-inspections and monitoring activities to identify and address quality risks proactively.
• Partner with automation, IT, and production teams to integrate quality principles into manufacturing processes.
• Drive continuous improvement initiatives by analyzing quality data and implementing effective solutions.
• Prepare for and participate in regulatory inspections and audits, demonstrating strong compliance knowledge.
• Maintain meticulous documentation, including quality records, change control documents, and quality reports.
• Provide expert guidance and training to team members on computer system quality and validation.
• Stay up-to-date with industry trends and emerging quality assurance best practices.

Qualifications:

• Bachelor's, Master's, or PhD degree in a relevant scientific or engineering discipline.
• Minimum of 3 years of experience in quality assurance within the biotechnology, pharmaceutical, or medical device industry.
• In-depth understanding of cGMP, FDA regulations, data integrity principles, and quality risk management.
• Proven ability to analyze complex data, identify trends, and implement corrective actions.
• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Strong attention to detail and a commitment to quality excellence.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is preferred.

Join Our Team

If you are a results-oriented professional with a strong quality mindset, we encourage you to apply. We offer a competitive salary, comprehensive benefits package, and opportunities for career growth in a dynamic and rewarding environment.