Senior Automation Systems Lead

PSC Biotech • San Francisco, CA

6d

About The Position

The Senior Automation Systems Lead provides technical and operational leadership for the support, maintenance, reliability, and continuous improvement of GxP manufacturing automation systems in a highly regulated life sciences manufacturing environment. The role leads service delivery and complex troubleshooting for Process Control Systems (PCS), SCADA platforms, historian systems, and associated operational technology (OT), keeping systems reliable, compliant, secure, and available to manufacturing operations.

The position is a primary technical contact for system owners and manufacturing stakeholders, and works across Manufacturing, Engineering, Quality, Validation, IT/OT Infrastructure, vendors, and managed service teams. It leads incident and problem resolution, system lifecycle and preventive maintenance activities, change management, cybersecurity and recovery activities, and continuous improvement initiatives. The role also provides technical direction to engineers, contractors, and managed service resources and supports knowledge transfer and sustainable long-term support.

Requirements

• 10+ years of experience supporting automation systems in GMP-regulated pharmaceutical, biotechnology, or life sciences manufacturing environments.
• 5+ years of experience leading automation support, engineering, or managed services teams.
• Demonstrated experience supporting business-critical manufacturing automation systems in a 24x7 operational environment.
• Strong hands-on experience with Rockwell Automation technologies, including FactoryTalk View SE and Rockwell PLC platforms, preferably ControlLogix.
• Experience with FactoryTalk AssetCentre and automation asset-management practices.
• Strong experience supporting Ignition SCADA platforms.
• Experience with MQTT-based architectures and Unified Namespace (UNS) concepts.
• Strong knowledge of AVEVA PI System and historian technologies; system administration experience is preferred.
• Experience supporting Windows Server environments and working with OT networking fundamentals.
• Knowledge of automation system backup, restoration, disaster recovery, patching, and lifecycle-management processes.
• Strong understanding of GMP documentation and change-control requirements for manufacturing automation systems.
• Working knowledge of GAMP 5, CSV/CSA methodologies, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
• Experience supporting Change Control, CAPA, deviation management, validation lifecycle, and audit activities.
• Demonstrated ability to troubleshoot complex automation and system-integration issues and lead structured root cause investigations.
• Ability to coordinate activities across Manufacturing, Engineering, Quality, Validation, IT/OT, vendors, and managed service teams.
• Strong technical leadership, communication, documentation, and stakeholder-management skills.

Nice To Haves

• Rockwell Automation certifications.
• Inductive Automation Ignition certification.
• AVEVA PI System administration experience.
• Experience with electronic quality and validation systems such as Veeva Vault, Kneat, or comparable platforms.
• Experience supporting both pilot-scale and commercial pharmaceutical or biotechnology manufacturing operations.
• Experience leading managed services transitions, support-model implementations, and knowledge-transfer programs.

Responsibilities

• Provide technical and operational leadership for GxP manufacturing automation and control systems, including PCS, SCADA platforms, historians, and supporting OT infrastructure.
• Serve as a primary technical point of contact for system owners, manufacturing stakeholders, Quality, Engineering, IT/OT, and managed service personnel.
• Lead support activities for Rockwell PLCs, FactoryTalk View SE, FactoryTalk AssetCentre, Ignition SCADA, MQTT infrastructure, Unified Namespace (UNS) architecture, and AVEVA PI Historian systems.
• Manage automation-related incidents, problems, service requests, and escalations in a 24x7 manufacturing support environment.
• Coordinate advanced troubleshooting, root cause investigations, and resolution of complex automation, controls, infrastructure, and system-integration issues.
• Monitor system availability, performance, alarm health, infrastructure status, and overall system reliability.
• Lead operational reviews and service reporting to ensure response, restoration, and issue-resolution expectations are met.
• Review technical solutions, system modifications, and enhancements for alignment with business, engineering, quality, and compliance requirements.
• Support firmware upgrades, software lifecycle activities, system patching, platform modernization, and technology refresh initiatives.
• Drive continuous improvement and reliability initiatives across manufacturing automation systems.
• Develop and maintain preventive maintenance strategies, system health checks, lifecycle roadmaps, and obsolescence management plans.
• Coordinate cybersecurity, patch management, backup verification, and disaster recovery activities for automation systems.
• Ensure automation work complies with applicable GxP requirements, site procedures, and established change-control processes.
• Support deviations, CAPAs, root cause investigations, audit responses, and other quality activities involving automation systems.
• Author and review change impact assessments, technical documentation, procedures, and SOPs.
• Maintain applicable data integrity, audit trail, backup, recovery, and system security requirements.
• Partner with Validation and Quality to determine testing, qualification, and validation requirements for system changes.
• Provide technical direction and oversight to engineers, contractors, and managed service resources supporting automation systems.
• Support knowledge-transfer activities and managed services transitions to maintain effective, sustainable long-term system support.

Benefits

• Medical, dental, and vision coverage; PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependent premiums.
• Insurance options including Employee Assistance Programs, Basic Life Insurance, and Long Term Disability.
• 401(k) and 401(k) matching.
• PTO, sick time, and paid holidays.
• Education assistance.
• Pet insurance.
• Fitness perks and discounted rates.
• Financial perks and discounts.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed