Senior Automation Systems Lead

PSC Biotech • San Francisco, CA

7d • $190,000 - $215,000

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 serves as a key technical lead for Process Control Systems (PCS), SCADA infrastructure, historian platforms, and associated operational technology (OT).

The position oversees day-to-day automation service delivery, complex troubleshooting, system lifecycle activities, preventive maintenance, and change management to keep systems reliable, compliant, secure, and available to manufacturing operations. It works cross-functionally with Manufacturing, Engineering, Quality, Validation, IT/OT Infrastructure, system owners, and managed service teams to resolve issues and implement sustainable improvements. The role also provides technical direction to engineers, contractors, and managed service resources and supports knowledge transfer and managed services transitions.

Requirements

• At least 10 years of experience supporting automation systems in GMP-regulated pharmaceutical, biotechnology, or life sciences manufacturing environments.
• At least 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.
• Experience with FactoryTalk AssetCentre and automation asset-management practices.
• Strong experience supporting Ignition SCADA platforms.
• Experience with MQTT-based architectures and Unified Namespace concepts.
• Strong knowledge of AVEVA PI System and historian technologies.
• 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.
• Rockwell PLC experience with ControlLogix is preferred.

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 for Rockwell PLCs, FactoryTalk View SE, FactoryTalk AssetCentre, Ignition SCADA, MQTT infrastructure, Unified Namespace architecture, and AVEVA PI Historian systems.
• Manage automation 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 reliability.
• Lead operational reviews and service reporting to track response, restoration, and issue-resolution expectations.
• 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 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 teams 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 and managed services transitions for sustainable long-term system support.

Benefits

• PSC pays 100% of qualifying employee medical premiums and 50% of qualifying dependent medical premiums.
• Dental and vision coverage.
• Employee Assistance Programs, Basic Life Insurance, Long Term Disability, and other insurance options.
• 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