Senior Automation Engineer (GMP)

Senior Automation Engineer (GMP)

Location: Pennington, NJ (Fully Onsite)
Employment Type: Full-Time, Permanent
Salary Range: $120,000 $150,000 per year
Industry: Biotechnology / Biopharmaceutical Manufacturing

About the Opportunity

We are seeking a Senior Automation Engineer to support the administration, maintenance, validation, and continuous improvement of automation systems within a regulated biopharmaceutical manufacturing environment.

This role focuses on SCADA systems, industrial automation, IT development, and GMP compliance. The successful candidate will work closely with cross-functional teams across IT, Manufacturing, Engineering, Quality Assurance, and Quality Control to ensure automation systems remain reliable, compliant, secure, and fit for operational use.

This is a hands-on technical role for an experienced automation professional with strong SCADA expertise and a background supporting computerized systems in a GMP-regulated environment.

Key Responsibilities

• Administer, maintain, and support site automation systems, including SCADA platforms, PLCs, notification systems, and computerized laboratory instruments.
• Support the installation, configuration, maintenance, backup, upgrade, validation, and retirement of automation systems throughout their lifecycle.
• Develop, execute, and maintain computer system validation documentation, including validation protocols, test scripts, test evidence, reports, and lifecycle documentation.
• Troubleshoot system issues, investigate production errors, perform root cause analysis, and implement corrective actions.
• Manage system enhancements, patches, upgrades, and configuration changes in accordance with established change control procedures.
• Monitor system integrity, availability, performance, security, and operational reliability.
• Administer user access and permissions while maintaining appropriate controls and documentation.
• Develop and improve SOPs, technical documentation, and system administration procedures.
• Collaborate with IT, Manufacturing, Facilities & Engineering, Quality Assurance, Quality Control, system owners, and external vendors to support automation projects and ongoing operations.
• Support the integration of bioprocess equipment and Process Analytical Technology (PAT) solutions.
• Maintain compliance with applicable GMP, data integrity, and computerized system validation requirements.
• Provide technical guidance and training on automation systems, applicable procedures, and site safety requirements.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Computer Science, Information Technology, Engineering, or a related technical field.
• Approximately 8+ years of relevant professional experience in industrial automation, IT automation, SCADA administration, or a related technical discipline.
• Hands-on experience with Wonderware / AVEVA System Platform (ArchestrA).
• Experience with Rockwell Automation FactoryTalk View SE.
• Strong IT development and technical troubleshooting skills, with an understanding of networking, system operations, and automation infrastructure.
• Previous experience working in a GMP-regulated biopharmaceutical, biotechnology, pharmaceutical, or comparable life sciences environment.
• Knowledge of computer system validation, equipment qualification, change control, and regulated system lifecycle management.
• Familiarity with applicable regulatory standards, including FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple projects and operational priorities while collaborating across technical and business teams.

Preferred Technical Experience

Experience with one or more of the following technologies and systems is beneficial:

• Allen-Bradley PLCs and RSLogix
• Wonderware / AVEVA System Platform and ArchestrA
• FactoryTalk View SE
• TopView notification systems
• Vaisala ViewLinc
• Cytiva UNICORN software
• Emerson DeltaV
• Repligen and Thermo Fisher Scientific bioprocess equipment and instruments
• Veeva Vault, SAP, Maximo, and Building Automation Systems (BAS)

Experience supporting single-use bioreactors, chromatography systems, ultrafiltration skids, and computerized QC laboratory instruments is also valuable.