Computer System Validation Engineer

Risk Assessment:

• Conduct risk assessments to identify potential issues and ensure that appropriate controls are in place.
• Develop and implement risk mitigation strategies.

Validation Execution:

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing systems.
• Execute test scripts and document results, ensuring that all deviations are recorded and addressed.

Documentation:

• Create and maintain comprehensive validation documentation, including validation plans, test scripts, deviation reports, and validation summary reports.
• Ensure that all documentation meets regulatory requirements and internal standards.

Compliance:

• Ensure that all computer systems comply with relevant regulations, such as FDA 21 CFR Part 11, GxP, and other applicable standards.
• Stay updated with industry best practices and regulatory changes to ensure ongoing compliance.

Collaboration:

• Work closely with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
• Provide training and guidance to team members on validation processes and regulatory requirements.

Continuous Improvement:

• Identify opportunities for process improvements and implement changes to enhance the efficiency and effectiveness of validation activities.
• Participate in internal and external audits and provide support for regulatory inspections.

Your Profile

You will have:

Education

• Degree in Engineering or Software (e.g. Computer Science, Life Sciences, Mechanical Engineering, or a related field)

Work Experience

• Minimum of 5 years of experience in computer system validation within a regulated industry, preferably in medical devices-
• Experience with validation of ERP systems, QMS software LIMS, MES, or other enterprise-level applications is preferred.

Specific Knowledge/Skills

• Strong understanding of validation principles, methodologies, and regulatory requirements.
• Excellent analytical and problem-solving skills.
• Proficiency in creating and executing validation documentation.
• Strong attention to detail and organizational skills.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Expertise in national and international Medical Device standards and regulations, Regulation (EU) 2017/745, ISO 13485:2016, MDSAP, MPDG, etc.
• At minimum fluent in English. German is an advantage.

Your ZEISS Recruiting Team:

Joe Taroni