Job DescriptionYour RoleThe Senior Automation Systems Lead will provide technical and operational leadership for the support, maintenance, reliability, and continuous improvement of GxP manufacturing automation systems within a highly regulated life sciences manufacturing environment. This role will serve as a key technical lead for Process Control Systems (PCS), SCADA infrastructure, historian platforms, and associated OT technologies.
The Senior Automation Systems Lead will oversee day-to-day automation service delivery, complex troubleshooting, system lifecycle activities, preventive maintenance, and change management while ensuring systems remain reliable, compliant, secure, and available to manufacturing operations. The individual will work cross-functionally with Manufacturing, Engineering, Quality, Validation, IT/OT Infrastructure, system owners, and managed service teams to resolve issues and implement sustainable system improvements.
- Provide technical and operational leadership for GxP manufacturing automation and control systems, including Process Control Systems, 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 within 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 appropriate response, restoration, and issue-resolution expectations are achieved.
- Review technical solutions, system modifications, and enhancements to ensure 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 is executed in accordance with applicable GxP requirements, site procedures, and established change-control processes.
- Support deviations, CAPAs, root cause investigations, audit responses, and other quality-related activities involving automation systems.
- Author and review change impact assessments, technical documentation, procedures, and SOPs.
- Ensure applicable data integrity, audit trail, backup, recovery, and system security requirements are maintained.
- Partner with Validation and Quality teams to determine appropriate 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 and sustainable long-term system support.
Requirements- 10+ years of experience supporting automation systems within 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.
Preferred Qualifications- 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.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more
- 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
Adhering to the requirements of U.S laws on pay transparency, the salary range expected for this role is set between $190,000 - $215,000. The rate offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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