Novozen Healthcare LLC
Automation Engineer
Location:
Gaithersburg, Maryland (Local candidates highly preferred)
Job Description:
We are seeking experienced Automation Engineers to support automation, controls, and cleanroom manufacturing operations within a regulated GMP environment. The ideal candidate will be able to work independently, handle complex system troubleshooting, and manage automation-related change controls with minimal oversight.
Key Responsibilities
Develop URS (User Requirement Specifications) in collaboration with end users and Quality teams.
Assess impact of automation changes on existing systems and document accordingly.
Design and implement automation solutions including equipment modules, I/O mapping, and PLC integration.
Troubleshoot and program Rockwell/Allen‑Bradley PLCs to support automated equipment in cleanroom manufacturing areas.
Support SCADA systems—primarily Ignition and Rockwell platforms.
Work with OSI PI Historian for data collection, data modeling, and historian configuration.
Interface with various industrial networks such as IO‑Link, Ethernet/IP, DeviceNet, and standalone equipment software.
Operate effectively within ISO 7 cleanrooms, performing aseptic gowning and following aseptic operation standards.
Ensure compliance with GMP, Quality Assurance, and Change Management procedures.
Understand equipment downtime scheduling and its impact on production operations.
Support both batch and continuous bioprocess manufacturing systems (up to 2000 L bioreactors).
Required Skills & Experience
5–12 years of relevant automation/controls experience.
Hands‑on experience working inside cleanrooms, including ISO 7 aseptic gowning.
Strong understanding of aseptic operations and cleanroom behavior.
Proven experience owning change controls within GMP environments (non‑negotiable).
Strong troubleshooting and/or programming ability with Rockwell PLCs.
Experience with Ignition SCADA is highly preferred.
Hands‑on experience with OSI PI Historian (required).
Familiarity with bioprocess/biotech manufacturing equipment is a strong plus.
Background in Science or Engineering (e.g., Chemistry, Pharmacy, Electrical Engineering, Automation).
Ability to work independently and lighten the workload—not requiring extended ramp‑up time.
Seniority level Mid‑Senior level
Employment type Contract
Job function Engineering, Production, and Manufacturing
Industries Automation Machinery Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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Gaithersburg, Maryland (Local candidates highly preferred)
Job Description:
We are seeking experienced Automation Engineers to support automation, controls, and cleanroom manufacturing operations within a regulated GMP environment. The ideal candidate will be able to work independently, handle complex system troubleshooting, and manage automation-related change controls with minimal oversight.
Key Responsibilities
Develop URS (User Requirement Specifications) in collaboration with end users and Quality teams.
Assess impact of automation changes on existing systems and document accordingly.
Design and implement automation solutions including equipment modules, I/O mapping, and PLC integration.
Troubleshoot and program Rockwell/Allen‑Bradley PLCs to support automated equipment in cleanroom manufacturing areas.
Support SCADA systems—primarily Ignition and Rockwell platforms.
Work with OSI PI Historian for data collection, data modeling, and historian configuration.
Interface with various industrial networks such as IO‑Link, Ethernet/IP, DeviceNet, and standalone equipment software.
Operate effectively within ISO 7 cleanrooms, performing aseptic gowning and following aseptic operation standards.
Ensure compliance with GMP, Quality Assurance, and Change Management procedures.
Understand equipment downtime scheduling and its impact on production operations.
Support both batch and continuous bioprocess manufacturing systems (up to 2000 L bioreactors).
Required Skills & Experience
5–12 years of relevant automation/controls experience.
Hands‑on experience working inside cleanrooms, including ISO 7 aseptic gowning.
Strong understanding of aseptic operations and cleanroom behavior.
Proven experience owning change controls within GMP environments (non‑negotiable).
Strong troubleshooting and/or programming ability with Rockwell PLCs.
Experience with Ignition SCADA is highly preferred.
Hands‑on experience with OSI PI Historian (required).
Familiarity with bioprocess/biotech manufacturing equipment is a strong plus.
Background in Science or Engineering (e.g., Chemistry, Pharmacy, Electrical Engineering, Automation).
Ability to work independently and lighten the workload—not requiring extended ramp‑up time.
Seniority level Mid‑Senior level
Employment type Contract
Job function Engineering, Production, and Manufacturing
Industries Automation Machinery Manufacturing, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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