GMP Automation & Controls Engineer — Biopharma

CAMRIS; Silver Spring (MD); On-site; USD 95,000 - 160,000; Full time

Job summary

CAMRIS is seeking an Automation and Controls Engineer to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. You will lead PLC/SCADA maintenance, device networking, CSV activities, and documentation within a cGMP environment.

You will manage automation scope for capital projects, coordinate with process engineers, ensure regulatory inspections readiness, and support IT/OT convergence with cybersecurity controls.

Qualifications

• BA/BS in engineering, computer science, or biotechnology and at least 6 years GMP automation experience in a GMP-regulated facility.
• Understanding of GMP manufacturing practices and regulated computerized systems.
• Experience with GMP documentation practices, change control procedures, deviation management, and regulatory inspection support (FDA, DISA, or equivalent).
• Experience managing subcontractors in capital projects or automation scopes.
• Strong problem-solving and the ability to work independently in a collaborative, cross-functional environment.

Responsibilities

• Maintain and document PLC/SCADA systems (ControlLogix, CompactLogix) and ladder logic.
• Configure and troubleshoot DeviceNet/Ethernet/IP networks; maintain network topology documentation.
• Support CSV activities per 21 CFR Part 11 and EU Annex 11, including IQ/OQ/PQ protocols and change control records.
• Maintain OT network infrastructure and collaborate on cybersecurity controls.
• Lead automation scope definition for capital projects and coordinate with process engineers.
• Assist regulatory inspections and document CAPAs for automation deviations.

Skills

GMP automation experience

Problem solving

Communication skills

Teamwork / cross-functional

Education

BA/BS in engineering, computer science, or biotechnology

Tools

Allen-Bradley PLCs

RSLogix 5000 / Studio 5000

FactoryTalk View

Ethernet/IP / ControlNet

Job description

CAMRIS is seeking an Automation and Controls Engineer to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. You will lead PLC/SCADA maintenance, device networking, CSV activities, and documentation within a cGMP environment.

You will manage automation scope for capital projects, coordinate with process engineers, ensure regulatory inspections readiness, and support IT/OT convergence with cybersecurity controls.