IT Computer and Software Validation Specialist

We are seeking a highly motivated and detail-oriented IT Computer and Software Validation Specialist to join our team. This role is crucial in ensuring the quality, reliability, and compliance of our computer systems and software applications, particularly within our regulated pharmaceutical or manufacturing environment. The ideal candidate will have 3-5 years of hands-on experience in Computerized System Validation (CSV) across various platforms and applications, including SAP qualification and experience with electronic Quality Management Systems (eQMS).Responsibilities:Participate in the full lifecycle of computer and software validation projects, including planning, requirements gathering, risk assessment, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and report generation.Develop and execute validation protocols, test scripts, and traceability matrices in accordance with relevant regulatory guidelines (e.g., GAMP 5, 21 CFR Part 11).Perform thorough testing of computer systems and software applications, documenting any deviations and working with relevant teams to resolve issues.Maintain and update validation documentation throughout the system lifecycle, ensuring compliance with internal procedures and regulatory requirements.Provide expertise in the validation of SAP S4HANA, including configuration, master data, and interfaces.Contribute to the validation and administration of our preferred eQMS, ideally Sparta Systems (TrackWise digital), as well as experience with EMS (Environmental Monitoring System), LIMS (Laboratory Information Management System Labware), and MES (Manufacturing Execution System), Jekson Track and Trace.Participate in the validation of IT infrastructure components relevant to regulated systems.Contribute to the validation efforts for Salesforce implementations and integrations.Experience with Track and Trace systems, with a preference for Jekson, is highly desirable.Collaborate effectively with cross-functional teams, including IT, Quality Assurance, Manufacturing, and Laboratory personnel.Assist in the development and maintenance of IT validation policies, procedures, and work instructions.Participate in internal and external audits related to computer and software validation.Stay current with industry best practices and regulatory changes related to CSV.Qualifications:Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.Minimum of 3-5 years of hands-on experience in Computerized System Validation (CSV) within a regulated environment (pharmaceutical, biotechnology, or manufacturing preferred).Proven experience in the validation of SAP systems (qualification).Experience with electronic Quality Management Systems (eQMS), preferably Sparta Systems (TrackWise).Familiarity with EMS (Environmental Monitoring System) and LIMS (Laboratory Information Management System) validation.Experience in the validation of IT infrastructure components.Experience with Salesforce validation is highly desirable.Experience with Track and Trace systems, preferably Jekson, is a strong advantage.Strong understanding of relevant regulatory guidelines (e.g., GAMP 5, 21 CFR Part 11).Excellent analytical, problem-solving, and documentation skills.Strong attention to detail and a commitment to quality.Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.Preferred Skills:Experience with other validation tools and methodologies.