Job TitleEvaluate the impact of validated computerized systems on existing work instructions and processes. Prepare and execute computer system validation protocols and generate comprehensive reports. Develop and maintain Installation Qualification (IQ) documentation. Collaborate with process owners to implement changes to work instructions and ensure compliance. Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed. Ensure adherence to company procedures, quality system regulations, and industry standards. Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques. Organize and track project progress, maintaining detailed documentation and status updates. Contribute to cross-functional projects and support milestone completion. Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making. Other duties may be assigned.Requirements Minimum 3 years of relevant validation experience with a Bachelor's degree in Engineering. Hands-on experience in Process and Computerized Systems Validation. Background in FDA-regulated industries (medical devices, pharmaceuticals, biotech).
Experience in medical devices or other highly regulated industry. Familiarity with SDLC processes.
Experience configuring and troubleshooting Windows 10 desktops (nice to have). Ability to work independently on moderately complex projects and mentor junior team members when needed. Knowledge & Technical Skills Must Have Investigation and root cause analysis skills. Technical writing proficiency. Strong organizational and communication skills (bilingual – English and Spanish). Knowledge of Process Validation and Computer Software Validation. Practical knowledge and demonstrated competence in validation and quality systems. Nice to Have Excellent overall SDLC experience. Technical knowledge of Windows 10 environments.