HW3
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
Programmable Logic Controllers (PLC) – e.g., Allen‑Bradley
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.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Manufacturing and Engineering
Pharmaceutical Manufacturing and Biotechnology Research
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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
Programmable Logic Controllers (PLC) – e.g., Allen‑Bradley
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.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Manufacturing and Engineering
Pharmaceutical Manufacturing and Biotechnology Research
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