Automation Engineer
About the job
A rapidly growing Cell & Gene Therapy CDMO is seeking a Senior Automation Engineer to join its onsite operations team in Pennington, NJ. This is a high-impact position responsible for managing and supporting critical automation infrastructure across manufacturing, facilities, quality control, and engineering operations. The role offers the opportunity to work with advanced biologics manufacturing systems, support cutting-edge cell and gene therapy production, and collaborate cross-functionally to drive reliability, compliance, and continuous improvement initiatives.
Key Responsibilities
- Administer and maintain site automation systems, including SCADA platforms, PLCs, computerized laboratory systems, and notification systems.
- Partner with Manufacturing, Engineering, Quality, and IT teams to support the full lifecycle of automation systems.
- Develop and execute validation protocols, reports, and lifecycle documentation for computerized systems.
- Support system implementation, qualification, maintenance, upgrades, and retirement activities.
- Monitor system performance, integrity, availability, and operational readiness.
- Troubleshoot technical issues, perform root cause investigations, and implement corrective actions.
- Manage software upgrades, patches, and enhancements while ensuring compliance with change control procedures.
- Support user access administration and data integrity initiatives.
- Author change controls, test scripts, and technical documentation.
- Serve as a subject matter expert for automation-related projects and system improvements.
- Evaluate and integrate new process technologies, automation platforms, and manufacturing equipment.
- Collaborate with vendors and internal stakeholders to ensure successful project execution and regulatory compliance.
- Support audit readiness, inspections, and validation activities within a GMP-regulated environment.
- Drive continuous improvement initiatives that enhance process efficiency and reliability.
Qualifications
- Bachelor's degree in Electrical Engineering, Computer Science, Engineering, Information Technology, or a related technical discipline.
- 8+ years of experience supporting automation systems within pharmaceutical, biotechnology, biologics, or other regulated manufacturing environments.
- Strong knowledge of SCADA systems, PLCs, industrial automation, and computer system validation.
- Experience supporting biologics manufacturing equipment and process control systems.
- Familiarity with automation platforms such as Rockwell Automation/Allen-Bradley, Wonderware, DeltaV, ViewLinc, Unicorn, or similar technologies.
- Knowledge of equipment qualification, computer system validation, and GMP compliance requirements.
- Understanding of regulatory standards including 21 CFR Part 11, Annex 11, and GAMP 5.
- Experience with IT networking, system administration, and cloud-based applications.
- Excellent troubleshooting, analytical, and problem-solving skills.
- Strong project management and technical documentation capabilities.
- Ability to effectively collaborate across Quality, Manufacturing, Engineering, and IT functions.
- Experience working within highly regulated biologics, pharmaceutical, or life sciences manufacturing environments is preferred.
Why Consider This Opportunity?
- Join a rapidly expanding organization supporting the future of cell and gene therapy manufacturing.
- Work with innovative automation technologies and advanced biologics production systems.
- Play a key role in supporting mission-critical manufacturing operations.
- Gain exposure to large-scale automation, validation, and digital transformation initiatives.
- Collaborate with highly skilled technical and operational teams in a fast-growing environment.
- Strong opportunities for professional development and career advancement.
- Competitive compensation package, comprehensive benefits, and long-term growth potential.
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