Senior Automation Engineer – Biologics Manufacturing Systems

DSJ Global

Pennington (NJ)

On-site

USD 110,000 - 150,000

Full time

17 hours ago

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Job summary

DSJ Global is seeking a Senior Automation Engineer to join our on-site team in Pennington, NJ. You will oversee automation infrastructure across manufacturing, facilities, QC, and engineering, enabling reliable biotech operations and regulatory compliance.

Ideal candidates bring 8+ years in regulated pharma/biotech environments, strong SCADA/PLC expertise, and proven ability to lead validation, change control, and cross-functional projects in a GMP setting.

Qualifications

Bachelor’s degree in a technical field and 8+ years in regulated environments.
Strong SCADA/PLC knowledge and validation experience.
Familiarity with GMP, 21 CFR Part 11, and lifecycle documentation.

Responsibilities

Maintain and administer site automation systems (SCADA, PLCs, lab systems).
Collaborate with Manufacturing, Engineering, Quality, and IT on full lifecycle.
Develop validation protocols, reports, and system documentation.
Support qualification, maintenance, upgrades, and retirements of systems.
Monitor performance, integrity, and readiness; investigate issues and drive CAPAs.
Manage software upgrades, changes, and validation within change control.
Assist with user access and data integrity initiatives.
Author change controls, test scripts, and technical docs.
Serve as SME for automation projects and improvements.
Evaluate new process tech and equipment; coordinate vendor work.
Support GMP inspections, audits, and validation activities.
Drive continuous improvement for efficiency and reliability.