SDMS Validation Engineer

Role: Scientific Data Management System (SDMS) Validation Engineer
Location: NEAR SHORE - South America/Canada
Length: Long term rolling contract

CSV engineers and for the applications: Discoverant, BIOVIA ELN, SDMS, Empower, LabX, SoftMax Pro.
Job Description:

Job Overview:
The SDMS (Scientific Data Management System) Validation Engineer is responsible for the qualification, validation, and compliance of scientific data management systems within laboratory environments, particularly in regulated industries such as pharmaceuticals, biotechnology, and healthcare. This role ensures that SDMS meets the regulatory, technical, and operational requirements by executing rigorous validation protocols, developing test strategies, and managing documentation for system functionality, data integrity, and compliance.
Key Responsibilities:

1. Validation Planning and Execution
   • Develop, execute, and document validation protocols (IQ/OQ/PQ) for SDMS systems.
   • Create comprehensive validation plans, testing scripts, and traceability matrices.
   • Conduct validation testing, assess test results, and ensure compliance with regulatory standards.
2. Regulatory Compliance and Documentation
   • Ensure compliance with industry standards, including FDA (21 CFR Part 11), GAMP 5, EU Annex 11, and other relevant regulations.
   • Manage the creation, review, and maintenance of validation documentation such as SOPs, validation reports, and technical specifications.
   • Conduct risk assessments and develop mitigation plans to ensure data integrity.
3. System Implementation and Quality Assurance
   • Collaborate with IT, QA, and laboratory teams during system implementation, upgrades, and troubleshooting.
   • Conduct audits of the system to ensure it meets validation and regulatory compliance requirements.
   • Verify system functionality, security controls, data backup, and recovery protocols.
4. Continuous Improvement and Process Optimization
   • Identify opportunities for enhancing SDMS processes, workflows, and efficiency.
   • Monitor and evaluate system performance post-implementation, providing recommendations for continuous improvement.
   • Stay updated on emerging regulations, validation methodologies, and industry trends.
5. Training and Support
   • Provide training and guidance to laboratory staff and users on SDMS functionalities and compliance protocols.
   • Offer troubleshooting support for system issues, liaising with vendors or IT for resolutions as needed.

Required Qualifications:

• Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• Experience:
  • Minimum of 2-3 years in SDMS validation, quality assurance, or a similar role in a regulated industry.
  • Experience with system validation, documentation practices, and data integrity compliance.
• Skills:
  • Strong understanding of validation requirements for SDMS in a GMP, GLP, or Google Cloud Platform environment.
  • Proficiency with validation lifecycle documents, risk management, and software development lifecycle (SDLC).
  • Knowledge of applicable regulatory standards (e.g., 21 CFR Part 11, GAMP 5).
  • Excellent communication, documentation, and project management skills

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.