| Role Description: | . Technical Process ExpertiseServe as the primary knowledge authority for specific systems, processes, or equipment (e.g., MES, SCADA, LIMS, Track Trace System (ACG, Systech, e-Logbooks).Understand end-to-end workflows, integration points, and regulatory requirements impacting the system or process.Provide guidance to teams during system upgrades, configuration changes, and process improvements.2. Implementation SupportCollaborate with IT, Engineering, Operations, and Quality to ensure smooth deployment of new systems or enhancements.Support troubleshooting of critical issues by providing advanced technical or process-level insights.Participate in vendor meetings to evaluate new solutions and ensure technical compatibility with site requirements.3. Compliance DocumentationEnsure systems and processes comply with applicable regulatory requirements (FDA, cGMP, 21 CFR Part 11, etc.).Develop, review, and maintain SOPs, work instructions, and training materials related to assigned systemsprocesses.Participate in audits and provide detailed responses to compliance-related inquiries.4. Training Knowledge TransferConduct training sessions for end-users, ensuring understanding of system functionalities and compliance requirements.Mentor junior team members and ensure cross-training within the department.Maintain a knowledge base for troubleshooting and best practices.5. Continuous ImprovementAnalyze systemprocess performance and recommend improvements to increase efficiency, data integrity, and user experience.Lead root cause analysis and implement correctivepreventive actions for recurring issues.Stay updated with industry trends and technology advancements to propose innovative solutions.Required QualificationsBachelors degree in Engineering, Information Technology, Life Sciences, or related field (or equivalent experience).5 years of experience in manufacturing, or automation within a regulated environment.Proven expertise in at least one specialized system or process (e.g., MES, LIMS, Track Trace, SCADA).Strong understanding of cGMP, FDA, and other global regulatory requirements.Excellent analytical, problem-solving, and communication skills.Preferred SkillsExperience with system integrations (ERP, MES, WMS, LIMS, SCADA, Track Trace).Ability to work in cross-functional and multi-site environments.Key CompetenciesExpert-level system knowledge.Strong leadership and collaboration skills.High attention to detail and compliance focus.Proactive problem solver with a continuous improvement mindset. |
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