What are the responsibilities and job description for the Automation Engineer position at Novozen Healthcare LLC?
Job Title: Automation Engineer
Location: Gaithersburg, Maryland (Local candidates highly preferred)
Duration: 6 Months (Possible extension)
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 2000L 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.