Senior Process Automation Engineer — Pharma (Onsite)

Genentech

Holly Springs (NC)

On-site

USD 99,820 - 185,380

Full time

14 days+

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Job summary

Genentech is seeking a Senior Project Engineer for Process Automation Systems to join our Automation and Digital Engineering team. You will own the full lifecycle of automation projects spanning DCS, PLC/SCADA, MES, and data historian platforms in pharmaceutical manufacturing, packaging, and warehouse operations.

Operate as SME, ensure GMP, FDA/EMA compliance, lead CSV, and drive digital manufacturing initiatives including IT/OT convergence.

Qualifications

Bachelor’s degree in Automation Engineering, Mechatronics, or related discipline.
5+ years of experience, preferably in the pharmaceutical or biotech industry.
Strong background in automation architecture design, project execution, commissioning and validation.
Experience with regulatory compliance (FDA, EMA) and GMP requirements.
Significant travel (50% or more) assignment required.

Responsibilities

Lead planning, design, specification, procurement, implementation, and qualification of process automation systems, including DCS, PLC/SCADA, MES, and data historian platforms.
Defining global automation architectures and system concepts, including feasibility studies and alignment with Roche engineering standards.
Managing automation system integration with process equipment, utility systems, robotics, packaging & inspection systems, and warehouse automation.
Acting as the technical and commercial interface to suppliers, integrators, engineering firms, and procurement teams, driving supplier innovation and performance.
Collaborating with multidisciplinary teams to align automation scope with project priorities and stakeholder expectations, providing regular progress updates and risk mitigation strategies.
Leading Computer System Validation (CSV), qualification activities, and commissioning efforts in compliance with GMP, FDA, EMA, and cybersecurity standards.
Supporting digital transformation initiatives through advanced process control, batch analytics, smart manufacturing, and IT/OT convergence solutions.