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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Specialist, Automation Engineering - **Company:** CareerCircle - **Location:** Rahway, NJ, United States (Remote available) - **Experience:** Expert - **Salary:** $87,300.0 - $137,400.0 - **Contract:** Permanent contract - **Skills:** Microsoft Excel, Microsoft Windows, Automation of Tests, Backup Devices, Microsoft Outlook, Encodings, Cyber Security, Computer Programming, Databases, Control Panels, Data Transmissions, Data Integrity, Desktop Computing, DeviceNet, Digital Data, Disaster Recovery, Supervisory Control and Data Acquisition (SCADA), Python (Programming Language), Ladder Logic, Microsoft Office, Profibus, Salesforce.Com, Virtualization Technology, Scripting, IT Architecture, Information Technology, Veeva, Allen-Bradley Factory Automation Equipment - **Published:** October 5, 2026 - **Apply:** https://www.careercircle.com/jobs/all/all/usa/nj/rahway/e80eff83-efa1-40c8-8e9a-ed821c009519 ## About the Role Empathy GE iFix Planning Auditing Teamwork Research Profibus Vaccines Scripting Embedding DeviceNet Scheduling Operations Leadership Management Automation Innovation Creativity Compassion Shift Work Scalability Investments Reliability Ladder Logic Digital Data Communication Investigation Risk Analysis Commissioning Change Control Cyber Security Prioritization Data Integrity Data Reporting Backup Devices Virtualization Lyophilization Pharmaceuticals Business Acumen Test Automation Problem Solving Instrumentation Project Scoping Small Molecules Safety Assurance Telephone Skills Financial Acumen Sterile Products Vendor Management Internal Auditing Change Management Technical Writing External Auditing Disaster Recovery Biopharmaceuticals Project Management Lean Manufacturing Influencing Skills Regulatory Filings PROFINET Standards Automation Systems Root Cause Analysis Process Development Process Engineering Contingent Workforce Lifecycle Management Process Optimization Validation Protocols System Administration Industrial Networking Information Technology Intellectual Curiosity Pharmaceutical Sciences Manufacturing Operations Manufacturing Automation Automation Systems Design Business Process Automation Interpersonal Communications Good Manufacturing Practices SIMATIC WinCC (SCADA System) Python (Programming Language) Cross-Functional Coordination Programmable Logic Controllers Continuous Improvement Process Cross-Functional Team Leadership Troubleshooting (Problem Solving) Information Technology Architecture Factory And Site Acceptance Testing Corrective And Preventive Action (CAPA) Supervisory Control And Data Acquisition (SCADA), * Bachelor's degree in an Engineering, Science, Information Technology, or related field. * Minimum 2 years of experience in process automation or equivalent. * Demonstrated a strong performance record and have excellent project management skills. * Highly developed communication, teamwork skills. Required Experience and Skills: * Strong knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems. * Hands-on experience maintaining validated automation systems, executing change control, investigations/CAPA, periodic reviews, system administration (e.g., user/role management, patching, backups, virtualization), and cybersecurity within GMP operations. * Proficiency with PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers. * Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams. * Proven root cause analysis and problem-solving skills; continuous improvement mindset. Preferred Experience and Skills: * Platforms/technologies: Allen-Bradley and/or Siemens PLCs; SCADA (iFix, WinCC OA, Ignition); OPC; fieldbuses (ASI/Profibus/Profinet/DeviceNet); instrumentation and panel design * Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting * Knowledgeable of S88 batch standards. * Experience in biologics, vaccine or bulk sterile manufacturing facilities is strongly preferred. * OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration * Experience with electronic validation and quality systems (e.g., Kneat/eVal, Veeva) * Prior leadership of installation/integration/qualification of automated equipment; experience on capital projects in GMP environments * Familiarity with planning/scheduling practices, vendor management, and business/financial acumen for project delivery * Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting * Demonstrated experience supporting audits/inspections and authoring/reviewing SOPs, validation protocols/reports., Automation, Automation Solutions, Change Management, Electronic Batch Records, Manufacturing Automation, Operations Engineering, Process Engineering, Process Optimization, Sterile Manufacturing, Troubleshooting Preferred Skills: Continuous Improvement, Cross-Functional Teamwork, PLC Automation, Equities Marketing Leadership Management Enthusiasm Innovation Resilience Accounting Salesforce Procurement Forecasting Coordinating Multitasking Supply Chain Market Trend Communication Presentations Target Market Prioritization Account Growth Direct Selling Plan Execution Sales Analysis Building Trust Professionalism Decision Making Technical Sales Customer Service Microsoft Office Technical Issues Sales Prospecting Microsoft Outlook Analytical Skills Product Promotion Sales Forecasting Profitable Growth Price Negotiation Selling Techniques Influencing Skills Value Propositions Technical Services Pricing Strategies Strategic Thinking Market Development Market Intelligence Strategic Marketing, Organizational Leadership Sales Territory Management Interpersonal Communications Project Portfolio Management Continuous Improvement Process Milestones (Project Management) Customer Relationship Management Organizational Change Management +0, Coordinating Communication Microsoft 365 Detail Oriented Microsoft Excel Customer Service Microsoft Office Personal Computers Business Valuation Financial Services Docking (Computers) Full Stack Development Business Transformation Ability To Meet Deadlines Verbal Communication Skills Troubleshooting (Problem Solving) ## Description The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational start-up phase. FLEx Sterile is positioned to play a pivotal role in delivering our clinical pipeline to patients worldwide, supporting a diverse range of product modalities including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). The facility supports the formulation and filling of clinical and developmental sterile products for critical program needs, such as new products in process development, products undergoing scale-up, launch and transfer to the supply network, and existing commercial products undergoing process optimization. Support encompasses both start-up operations (FLEx Sterile1) and a new capital expansion (FLEx Sterile2). The Specialist, Automation Engineering - role will provide end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply (PSCS), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures the reliable and compliant operation of process automation and OT/IT systems that enable formulation, filling, lyophilization, and associated support activities for clinical and development sterile products. This position supports start-up operations and new capital investments in the clinical supply area, including automation lifecycle management, data and analytics, and site representation on capital projects. Off-shift (second shift and weekend) or extended shift work will be required on an intermittent basis to support manufacturing operations. This role will be an onsite automation support role and directly reports to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead. Primary Responsibilities: * Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews) * Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization), including on-floor troubleshooting, root cause analysis, and performance/batch reliability improvements * Implement and sustain platform automation solutions, reporting, and visualization to meet operational and compliance needs; keep documentation, SOPs, drawings, configurations, PMs, and inventories inspection ready. * Lead and participate in automation system changes, investigations, CAPAs; represent automation and data integrity during internal/external audits and inspections. * Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings. * Serve as site automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive continuous improvement. * Represent automation in capital projects, embedding OT/IT architecture, cybersecurity, data integrity, and validation requirements in project scope and deliverables. * Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification (AIOQ) of new automated equipment and systems; author/execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT. * Evaluate and plan automation/IT expansions, replacements, upgrades, and obsolescence remediation to ensure quality, stability, scalability, and supportability. * Partner with enterprise/divisional IT, global infrastructure, and risk/security to align standards and manage user/role administration, patching, backups, disaster recovery, and virtualization in GMP operations. * Collaborate with GES, FM/GWES, Quality (product/equipment QA and digital data quality -DDQ), Manufacturing Operations, OEM vendors/system integrators to deliver reliable, compliant automation operations. * Supervise and coordinate contract engineers/vendors and manage workload and deliverables. * Develop and support data, reporting, analytics, and visualization solutions using historian/SCADA sources to monitor asset health and drive reliability improvements. * Troubleshoot across controls, instrumentation, electrical, software, and industrial networking layers; apply lean and continuous improvement principles to stabilize and optimize automation system performance. * Off-shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations., * Direct impact enabling sterile product development from lab to clinic through robust, compliant automation * Ownership across automation lifecycle, troubleshooting, and capital initiatives * Collaboration with world-class operations, quality, engineering, IT, and security teams