21 Cfr Part 11 Engineer Jobs

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Senior Automation Engineer

E Tech Group Portsmouth, NH

Portsmouth, NH

Today

Full time Senior 21 Cfr Part 11 Automation

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Job Description

The Senior Automation Engineer role at E Tech Group focuses on end-to-end process automation engineering and system integration, covering design through training. This position also supports continuous and batch control projects and serves as an automation subject matter expert.

Responsibilities

Lead or contribute to projects covering the design, configuration, and testing of continuous and batch control applications.
Review project scope and financials, and coordinate work through project schedules and budgets in collaboration with project leadership; identify change orders and justify changes to Project Management to support completion of all deliverables to client satisfaction.
Provide high-priority technical solutions and advisory support to project leadership and/or customers to maintain customer satisfaction.
Maintain flexibility for work schedule and travel, if needed, to support design, development, and start-up of control systems at client facilities.
Act as an automation Subject Matter Expert.
Represent and embody E Tech Group Core Values, prioritizing success for E Tech Group, clients, and professional development of associates.

Required Qualifications

PLC Programming using Rockwell Studio5000 and RSLogix5000.
5+ years of industry experience delivering automation projects for process plants, preferably within the Life Sciences domain.
BS Engineering degree or equivalent educational background.
Strong attention to detail, solid technical aptitude, and a desire to learn new technologies.
Knowledge of industry and regulatory standards, including design criteria and codes relevant to Instrumentation and Controls.
Knowledge of process instrumentation specifications, installation and troubleshooting, and control panel design, check-out, commissioning, and troubleshooting.
Ability to develop process control system applications using Siemens PLCs, WinCC Unified Scada, LAB-X, PAS-X, and Aveva PI Historian.
Strong understanding of object-oriented software development and delivery methodologies.
Experience designing, implementing, maintaining, and troubleshooting virtual server-based control system architectures, including control system network topology such as Ethernet, Ethernet/IP, ControlNet, and DeviceNet.
Hands-on capability to rapidly troubleshoot and resolve equipment and instrument issues during start-up and commissioning, including complex system testing.
Experience working on customer sites supporting installation and commissioning of equipment and systems.
Collaboration and teamwork mindset (described as a DNA comprised of collaboration and teamwork).

Technologies

Rockwell Studio5000, RSLogix5000
Siemens Programmable Logic Controllers (PLC)
WinCC Unified Scada, LAB-X, PAS-X
Aveva PI Historian
ISA S88 Batch standard, ISA S95 Controls System Architecture standard
GAMP 5, cGMP, 21 CFR Part 11
Ethernet, Ethernet/IP, ControlNet, DeviceNet

Benefits

401k + match + prompt enrollment
100% vested upon entry
Prompt enrollment into Medical, Dental, and Vision benefits
Generous paid time off including paid vacation, paid holidays, paid family leave, and sick time off
Training and continuing education from day one

Location and Work Style

Portsmouth, NH (hybrid)
Local driving travel may be required

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