The OT Manufacturing Process Analyst supports the implementation, monitoring, and optimization of operational technology (OT) systems that drive manufacturing efficiency, data integrity, and regulatory compliance in a pharmaceutical manufacturing environment. This role involves analyzing manufacturing data, troubleshooting OT systems, and collaborating with cross-functional teams to improve operational workflows.
Key Responsibilities:
- OT Systems Support and Analysis:
- Assist in the design, deployment, and maintenance of OT systems such as SCADA, MES, DCS, and PLCs.
- Perform system diagnostics and troubleshooting to resolve issues impacting production processes.
- Analyze OT system performance and recommend improvements or upgrades to optimize manufacturing operations.
- Data Collection and Reporting:
- Support the collection, analysis, and interpretation of data from OT systems to monitor production processes and KPIs.
- Generate reports on manufacturing performance, process deviations, and system utilization for management and operations teams.
- Identify data trends and work with teams to implement process improvements or corrective actions.
- Process Monitoring and Optimization:
- Monitor manufacturing processes and production workflows to ensure efficient OT system integration and utilization.
- Collaborate with production and engineering teams to optimize manufacturing processes through automation and OT system enhancements.
- Recommend and implement process automation improvements based on data analysis and OT system capabilities.
- Compliance and Regulatory Support:
- Ensure all OT systems are aligned with pharmaceutical industry regulations (e.g., GxP, 21 CFR Part 11, Data Integrity).
- Support validation, documentation, and audit readiness of OT systems as required by regulatory authorities.
- Assist in preparing system validation documents, risk assessments, and change management records.
- Collaboration with IT and Production Teams:
- Work closely with IT and manufacturing teams to ensure the seamless integration of OT systems with IT infrastructure.
- Assist in OT system patching, updates, and cybersecurity measures, following the organization’s security protocols.
- Participate in cross-functional team meetings to communicate OT system performance, data insights, and potential improvements.
- Continuous Improvement Initiatives:
- Identify and analyze opportunities to enhance manufacturing efficiency and reduce downtime through improved use of OT systems.
- Support continuous improvement initiatives by providing data insights and technical expertise on OT system capabilities.
- Collaborate on digital transformation projects and the introduction of new OT technologies or systems.
- Project Support:
- Assist with the implementation of OT-related projects, ensuring alignment with project goals, timelines, and resources.
- Participate in system testing, validation, and documentation during project rollouts or upgrades.
- Coordinate with external vendors or contractors for system installations, upgrades, and troubleshooting.
Required Skills and Qualifications:
- Bachelor’s degree in Engineering, Computer Science, Information Technology, or a related field.
- 3+ years of experience in an OT or manufacturing environment, preferably within the pharmaceutical or life sciences industry.
How to Apply
If you think you are a suitable candidate, please email your updated resume to [email protected], mentioning the respective position in the subject line of your email.
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