Automation & OT Engineer
5 days ago
Automation & Operational Technology (OT) Engineer
Location:
Maryland (Washington DC–Baltimore Area) | On-Site | 6-Month Contract (Option to Extend)
We are seeking a highly skilled Automation & OT Engineer to support our pharmaceutical manufacturing operations in the Washington DC–Baltimore area.
This role offers hands-on involvement with Distributed Control Systems (DCS) and other automation technologies that drive GMP-compliant production, utilities, and laboratory environments.
About the Role
As an Automation & OT Engineer, you will be responsible for maintaining, troubleshooting, and enhancing automation and control systems—including DCS, PLCs, SCADA, and related GMP-critical infrastructure.
You will ensure these systems operate safely, securely, and in full compliance with Good Manufacturing Practice (GMP), 21 CFR Part 11, and Annex 11 regulations.
You'll play a key role in system lifecycle management (SLC), validation, change control, and data integrity, helping to sustain a compliant and resilient automation environment for pharmaceutical manufacturing and utilities.
Key Responsibilities
- Design, implement, and support automation and control systems, with an emphasis on DCS platforms used in pharmaceutical production and utilities.
- Provide day-to-day technical support for GMP-regulated OT systems, ensuring maximum uptime, regulatory compliance, and data integrity.
- Lead and participate in system lifecycle management (design, commissioning, qualification, validation, and decommissioning) for DCS, PLC, and SCADA systems.
- Execute and support CAPEX and OPEX projects, including DCS expansions, control strategy enhancements, and infrastructure upgrades.
- Develop and maintain system documentation, including design specifications, functional specifications, configuration records, and change control documentation.
- Ensure all systems meet GMP, 21 CFR Part 11, Annex 11, and data integrity requirements for electronic records and audit trails.
- Partner with IT and Cybersecurity teams to strengthen OT network segmentation, patch management, and cyber risk mitigation for automation systems.
- Collaborate cross-functionally with Engineering, Quality, Manufacturing, and Validation to drive process reliability, efficiency, and compliance improvements.
Key Systems You'll Support
- Distributed Control Systems (DCS) – e.g., DeltaV
- Programmable Logic Controllers (PLC) - e.g, Allen-Bradley
- Environmental Monitoring Systems (EMS)
- Building Automation Systems (BAS)
- Process Control Systems (PCS)
- Manufacturing Execution Systems (MES / EBR)
- Laboratory Information Management Systems (LIMS)
- SCADA and PLC-based control systems
What We're Looking For
- 3–5 years of experience in Automation, OT, or Process Control Engineering within GMP-regulated industries (pharmaceuticals, biotech, or life sciences).
- Hands-on experience with DCS platforms and automation control strategies for GMP manufacturing.
- Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and Annex 11 compliance.
- Familiarity with OT/ICS cybersecurity, network architectures, and system hardening.
- Proven ability to troubleshoot, document, and communicate effectively in a regulated environment.
- Experience with system validation, change control, and audit readiness processes.
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