Senior Automation Engineer

Description:

The Automation Engineer designs, implements, qualifies, and supports automation and control systems for sterile pharmaceutical manufacturing. The role ensures reliable, compliant operation of PLCs, VFDs, HMI/SCADA, DCS, BMS/EMS, instrumentation, and industrial network systems. Working with Manufacturing, Quality, Validation, IT/OT, vendors, and integrators, the engineer supports capital projects, technology transfer, commissioning, qualification, troubleshooting, lifecycle management, and continuous improvement for sterile processing and packaging operations.

Essential Functions:

• Develops and maintains automation and controls solutions for sterile manufacturing equipment, utilities, and facilities. Prepares or reviews user requirements, functional and design specifications, control narratives, I/O lists, alarm strategies, network architecture, and configuration documentation. Programs, configures, tests, and supports PLC, VFD Programming, HMI/SCADA, distributed control system, BMS/EMS, historian, instrumentation, drives, motion-control, and related systems while maintaining approved configuration baselines and lifecycle plans.
• Leads or executes assigned automation workstreams for new equipment, facility upgrades, technology transfer, and process improvements. Coordinates system integrators, equipment vendors, contractors, Manufacturing, Quality, Validation, and IT/OT. Supports design reviews, factory and site acceptance testing (FAT/SAT), commissioning, startup, automation qualification, and IQ/OQ/PQ activities; verifies traceability to approved requirements and ensures timely turnover of complete technical documentation.
• Provides day-to-day technical support for automated sterile manufacturing and packaging systems. Diagnoses control, instrumentation, communication, sequence, interlock, alarm, and equipment-performance issues; analyzes system and historian data; performs root-cause analysis; and implements sustainable corrective actions. Supports planned shutdowns, maintenance, calibration, production changes, and after-hours response when required to protect product quality, personnel safety, and reliable operations.
• Compliance, Data Integrity, and Quality Systems: Ensures automation changes and computerized system records comply with cGMP, good documentation practices, applicable electronic-record requirements, data-integrity principles, cybersecurity controls, and approved site procedures. Initiates or supports change controls, impact and risk assessments, deviations, investigations, CAPA, access reviews, audit-trail reviews, backup and recovery verification, periodic reviews, and system retirement activities.
• Creates and maintains SOPs, work instructions, system inventories, drawings, code and configuration records, preventive-maintenance requirements, and training materials. Trains operations and maintenance personnel on automation-system operation and troubleshooting. Identifies and implements improvements that enhance reliability, compliance, process capability, cycle time, yield, alarm effectiveness, and obsolescence management.

Additional Responsibilities:

• Maintains automation inventories, source-code and configuration backups, recovery procedures, network diagrams, licenses, spare-parts information, and obsolescence plans in an inspection-ready state.  Reviews P&IDs, control and electrical drawings, loop diagrams, cause-and-effect matrices, specifications, vendor documents, calibration records, and maintenance records for automation impact.  Coordinates controlled implementation windows and confirms that approved changes, trained personnel, calibrated instruments, backups, and rollback plans are available before execution.

Education:

• Bachelors Degree (BA/BS) Electronics Engineering, Mechatronics Engineering, Electrical Engineering, Automation/Controls Engineering, or a closely related engineering field - Required
• Master Degree (MS/MA) Electronics, Mechatronics, Electrical, Automation/Controls Engineering, or a related technical field - Preferred

Experience:

• 5 years or more in Automation, controls, or electrical engineering experience in sterile or aseptic GMP pharmaceutical, biotechnology, or life-sciences manufacturing
• 5 years or more in Experience in sterile or aseptic manufacturing

Specialized Knowledge:

• • Advanced working knowledge of industrial automation platforms and architectures, including PLC, HMI/SCADA, DCS, BMS/EMS, process historians, instrumentation, drives, and industrial communication networks. • Ability to develop and review automation requirements, functional and design specifications, control narratives, I/O lists, alarm and interlock strategies, test scripts, traceability matrices, and qualification documentation.  Working knowledge of cGMP, risk-based computerized system validation, GAMP principles, electronic records and signatures, data integrity, change control, deviation management, CAPA, and inspection-ready documentation. • Strong troubleshooting and root-cause analysis capability across electrical, electronic, controls, software, network, instrumentation, and equipment interfaces in a sterile manufacturing environment. • Effective project coordination, technical writing, vendor management, and cross-functional communication skills; proficiency with Microsoft Office and familiarity with engineering drawing, maintenance, quality, and validation systems.

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $120,000 to $145,000 per year.   Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected]. Requests will be handled confidentially and in accordance with applicable laws.