Senior Automation Engineer, Drug Product-Aseptic Filling

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Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Wilson North Carolina United States of America

Job Description:

About Innovative Medicine

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The Automation organization is a dedicated team of professionals with diverse technical expertise responsible for the implementation validation qualification and lifecycle support of ISA-95 Level 1 and Level 2 manufacturing automation systems applicable interfaces and Level 3 recipe and manufacturing-system integration. The team ensures that automated systems are fit for intended use and comply with applicable regulatory requirements company manufacturing standards data-integrity expectations and cybersecurity requirements throughout the system lifecycle.

Reporting to the Drug Product Manufacturing Lead within the Site Automation organization the Automation Engineer Drug Product Aseptic Filling provides technical automation and controls engineering ownership for the assigned aseptic filling area. This is an automation engineering role with direct accountability for manufacturing control systems and automation delivery; Process Engineering is a key partner but is not the functional scope of this position.

The role is responsible for the design implementation qualification start-up support troubleshooting and lifecycle management of automation solutions for Drug Product aseptic filling operations and their interfaces to site manufacturing systems. The engineer will work closely with Manufacturing Process Engineering Quality Computerized System Validation (CSV) OT Infrastructure MES Digital equipment suppliers OEM controls teams and system integrators.

Key Responsibilities:

• Serve as the area Automation Engineer for Drug Product aseptic filling and provide direct technical ownership of the automation/controls scope under the DP Manufacturing Lead.

• Support end-to-end automation delivery from concept and detailed design through controls development FAT/SAT construction support commissioning qualification start-up handover troubleshooting and steady-state lifecycle support.

• Provide technical oversight for automation solutions supporting aseptic filling/finish operations and associated highly automated Drug Product equipment including applicable isolator or barrier technologies machine controls batch/sequence control SCADA/HMI industrial networks robotics and site-system interfaces.

• Review and challenge OEM and system-integrator automation designs software/configuration functional and design specifications control narratives system architectures interface definitions alarms/interlocks and test documentation to ensure alignment with site and global automation standards.

• Develop implement review and troubleshoot PLC/DCS/HMI/batch and machine-control changes within the assigned area; ensure software and configuration are maintainable standardized documented and appropriately controlled.

• Plan support and execute automation FAT/SAT commissioning qualification and start-up activities; lead technical issue resolution and drive automation punch-list items to closure.

• Travel domestically and internationally as required to supplier/OEM system-integrator and Johnson & Johnson affiliate sites for FAT technical training knowledge transfer and automation readiness.

• Support automation interfaces to MES historian recipe/data platforms and other site systems; ensure reliable data flow traceability and system integration for Drug Product manufacturing operations.

• Author review and execute automation-related validation and qualification documentation; support risk assessments investigations deviations CAPA change controls and regulatory/internal inspections.

• Apply sound automation engineering principles cGMP requirements GAMP 5 practices data-integrity expectations cybersecurity controls and lifecycle-management standards throughout the system lifecycle.

• Partner with Manufacturing and Process Engineering on process requirements while retaining technical ownership of the automation/controls solution. Translate approved process and equipment requirements into robust testable automation functionality.

• Coordinate technically with equipment vendors OEM controls teams system integrators CSV OT Infrastructure MES Digital Quality and other partners to deliver an integrated and supportable solution.

• Support operational readiness through training documentation maintenance/support models spare-parts considerations disaster-recovery/business-continuity planning and transfer of automation-system knowledge to the site organization.

• Use automation performance data and operational experience to identify continuous-improvement opportunities in reliability system performance validation efficiency and manufacturing support.

Qualifications

Education:

• A minimum Bachelors degree in Engineering Computer Science Science or a related technical field; required

Experience and Skills:

Required:

• Minimum of 6 years of progressive automation and controls engineering experience in pharmaceutical or biopharmaceutical manufacturing.

• Direct technical ownership of automated manufacturing systems in a cGMP environment with hands-on responsibility for automation/controls scope supporting manufacturing operations and/or capital projects.

• Proven Drug Product automation experience supporting aseptic or sterile manufacturing including automated filling inspection assembly packaging or related highly automated systems.

• Hands-on experience with ISA-95 Level 1 and Level 2 automation systems including PLC and/or DCS controls SCADA/HMI batch or sequence control machine controls industrial networks communication protocols OT infrastructure and associated hardware and interfaces.

• Experience developing reviewing implementing and troubleshooting automation software system configurations and engineering deliverables including functional/design specifications control narratives interface definitions alarm and interlock requirements and system architectures.

• Proven automation project execution experience including OEM and system integrator coordination controls design reviews FAT/SAT commissioning qualification start-up support troubleshooting and automation change control.

• Solid understanding of ISA-88 and ISA-95 standards and their application within regulated manufacturing environments.

• Knowledge of cGMP and computerized system validation expectations including GAMP 5 21 CFR Part 11 EU GMP Annex 11 data integrity and risk-based validation principles.

• Experience integrating manufacturing automation with Level 3 systems such as MES historian recipe management data platforms and related business or quality systems.

• Strong written and verbal communication skills with the ability to partner optimally across Automation Manufacturing Process Engineering Quality CSV OT Infrastructure Digital OEM system integrator and project teams while maintaining clear ownership of automation/controls deliverables.

• Ability and willingness to support project travel and on-site execution needs including periodic international travel to supplier/OEM system integrator and Johnson & Johnson affiliate sites for training FAT automation testing and related project activities.

• Candidates whose experience is limited to process engineering validation manufacturing operations or equipment engineering without direct hands-on automation/controls responsibility will not meet this requirement.

Preferred:

• Direct automation engineering experience with aseptic filling/finish equipment and associated isolator or restricted-access barrier technologies.

• Experience with batch/sequence control machine controls robotics motion control and integration of aseptic filling equipment with MES and historian platforms.

• Experience delivering automation scope for a large pharmaceutical capital project from design through controls development FAT/SAT commissioning qualification start-up and operational handover.

• Hands-on experience with platforms such as Rockwell Automation Siemens Emerson DeltaV OSI PI Werum PAS-X or comparable PLC DCS SCADA/HMI historian and MES technologies.

• Experience with reliability engineering automation lifecycle management operational readiness and maintenance/support strategy development.

• Good understanding of Industry 4.0 Industrial Internet of Things advanced analytics and evolving digital capabilities used to transform biopharmaceutical manufacturing.

• Experience working with multiple OEMs engineering partners automation vendors and system integrators in a global or multi-site organization.

Other:

• This position will be located in Wilson North Carolina and will require full time on-site support. However the design of the facility will occur at an Engineering firm with frequent travel (> 25%) required until the project shifts to the plant site of Wilson NC

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If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Artificial Intelligence (AI) Controls Compliance Critical Thinking Industrial Robotics Industry Analysis Innovation Lean Supply Chain Management Machine Learning (ML) Management Systems Implementation Organizing Problem Solving Project Management Prototyping Robotic Automation Science Technology Engineering and Math (STEM) Application Smart Systems Technologically Savvy

Required Experience:

Senior IC