Katalyst Healthcares and Lifesciences
Automation Engineer
Katalyst Healthcares and Lifesciences, Walkersville, Maryland, United States, 21793
Job Description
The Automation & Operational Technology (OT) Engineer is responsible for delivering technical hands‑on support for site-based automation and OT systems. This role ensures the integrity, reliability, security, and compliance of OT infrastructure and industrial automation platforms across manufacturing, utilities, quality control, and laboratory environments.
Key systems supported include Environmental Monitoring Systems (EMS), Building Automation Systems (Client), Process Control Systems (PCS), Manufacturing Execution Systems (MES/EBR), and Laboratory Information Management Systems (LIMS). The position supports system lifecycle management from design through validation, contributes to CAPEX/OPEX projects, and plays a key role in ensuring data integrity, cybersecurity, and regulatory readiness in line with GMP, 21 CFR Part 11, and Annex 11 requirements.
Responsibilities
Design, implement, and maintain automated equipment and systems to optimize manual processes.
Conduct automated tests to ensure performance, reliability, and integrity of automation systems.
Provide hands‑on technical support for OT systems including EMS, Client, PCS, MES/EBR, and LIMS.
Manage lifecycle activities: design, configuration, validation, maintenance, and upgrades.
Identify and implement automation opportunities to improve efficiency and production outcomes.
Troubleshoot and resolve automation/OT system issues, minimizing downtime.
Develop and maintain system documentation, including manuals and change records.
Ensure compliance with GMP, 21 CFR Part 11, Annex 11, and data integrity standards.
Support CAPEX and OPEX projects with technical input and system integration.
Contribute to regulatory inspections, audits, and cybersecurity initiatives.
Requirements
3‑5 Years Experience.
Knowledge of PLCs, SCADA, DCS, and industrial communication protocols.
Hands‑on experience with EMS, Client, PCS, MES, or LIMS.
Understanding of GMP, 21 CFR Part 11, Annex 11, and data integrity.
Strong troubleshooting, problem‑solving, and communication skills.
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The Automation & Operational Technology (OT) Engineer is responsible for delivering technical hands‑on support for site-based automation and OT systems. This role ensures the integrity, reliability, security, and compliance of OT infrastructure and industrial automation platforms across manufacturing, utilities, quality control, and laboratory environments.
Key systems supported include Environmental Monitoring Systems (EMS), Building Automation Systems (Client), Process Control Systems (PCS), Manufacturing Execution Systems (MES/EBR), and Laboratory Information Management Systems (LIMS). The position supports system lifecycle management from design through validation, contributes to CAPEX/OPEX projects, and plays a key role in ensuring data integrity, cybersecurity, and regulatory readiness in line with GMP, 21 CFR Part 11, and Annex 11 requirements.
Responsibilities
Design, implement, and maintain automated equipment and systems to optimize manual processes.
Conduct automated tests to ensure performance, reliability, and integrity of automation systems.
Provide hands‑on technical support for OT systems including EMS, Client, PCS, MES/EBR, and LIMS.
Manage lifecycle activities: design, configuration, validation, maintenance, and upgrades.
Identify and implement automation opportunities to improve efficiency and production outcomes.
Troubleshoot and resolve automation/OT system issues, minimizing downtime.
Develop and maintain system documentation, including manuals and change records.
Ensure compliance with GMP, 21 CFR Part 11, Annex 11, and data integrity standards.
Support CAPEX and OPEX projects with technical input and system integration.
Contribute to regulatory inspections, audits, and cybersecurity initiatives.
Requirements
3‑5 Years Experience.
Knowledge of PLCs, SCADA, DCS, and industrial communication protocols.
Hands‑on experience with EMS, Client, PCS, MES, or LIMS.
Understanding of GMP, 21 CFR Part 11, Annex 11, and data integrity.
Strong troubleshooting, problem‑solving, and communication skills.
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