CSV PERSON

As a Computerized Software Validation Engineer, your primary responsibility is to ensure the quality, compliance, and validation of computerized software systems used in various industries, and specifically throughout Eurofins sites. You will be involved in the validation process from start to finish, ensuring that software systems meet regulatory requirements and industry standards.

Key Responsibilities:

Validation Planning: Develop and execute validation plans and strategies for computerized software systems, considering regulatory guidelines and company policies.

Compliance Assessment: Evaluate software systems to ensure compliance with relevant regulations, standards, and guidelines, such as FDA (Food and Drug Administration) regulations or Good Manufacturing Practices (GMP) - Advantage !!

Validation Documentation: Prepare and review validation documentation, including URS, validation protocols, test scripts, traceability matrices, and validation reports.

Test Execution: Execute test protocols to validate software functionality, performance, and reliability.

Risk Analysis: Identify and assess risks associated with software systems and develop risk mitigation strategies.

Collaboration: Collaborate with cross-functional teams, including IT personnel, quality assurance, lab technicians, and other people throughout the organization to ensure effective validation and compliance of software systems.

Training and Support: Provide training and guidance to other team members and stakeholders on validation processes, procedures, and best practices.

Continuous Improvement: Stay updated with regulatory requirements, industry trends, and technological advancements related to software validation. Propose and implement process improvements to enhance efficiency and effectiveness.

Qualifications and Skills:

Bachelor's degree in computer science, software engineering, or a related field (relevant work experience may be accepted in lieu of a degree)

Strong understanding of software development life cycle (SDLC) and software validation principles.

Knowledge of regulatory guidelines and standards, such as FDA regulations, GMP, or ISO 13485 and GAMP5 -Advantage!!

Experience in developing and executing validation plans and protocols

Proficiency in testing methodologies, tools, and techniques

Excellent analytical and problem-solving skills

Strong attention to detail and ability to work with precision

Effective communication and collaboration skills to work in cross-functional teams

Ability to adapt to changing priorities and work independently with minimal supervision

Proficient in English, both writing and conversational.

Note: The job involves traveling throughout European sites at least once a month and relocation to two months or more – foreign nationality - Advance.