Automation Engineering Manager, Drug Product Manufacturing Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

People Leader

All Job Posting Locations:

Wilson North Carolina United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at more and apply to this exciting new role!

Reporting to the Site Automation Lead the Automation Engineering Manager Drug Product Manufacturing Lead provides technical and organizational leadership for Drug Product automation. This is an automation engineering leadership role with direct accountability for manufacturing controls and automation systems; Process Engineering is a key partner but is not the functional scope of this position. The role is accountable for the automation strategy architecture design delivery qualification start-up operational readiness support and lifecycle management of automation solutions across formulation aseptic filling optical and visual inspection device assembly packaging robotics material handling and associated manufacturing interfaces.

The new facility and production processes are envisioned to be highly automated with data shared across multiple platforms to support production from material receipt through formulation aseptic filling inspection device assembly packaging and final product disposition. Data generated at each stage of production will be shared across business information and control systems to support process monitoring advanced analytics predictive models operational decision-making and disposition support.

Key Responsibilities:

• Lead coach and develop the Drug Product automation team and extended delivery organization including automation engineers controls engineers system integrators OEM automation teams and contractors; provide resource planning technical direction capability development performance alignment and delivery accountability.

• Define and implement the Drug Product automation strategy technical scope control-system architecture standards software and configuration practices and lifecycle roadmap; ensure the resources governance and processes required for successful automation delivery are in place.

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

• Lead the technical design authority for Drug Product automation solutions supporting formulation aseptic filling optical and visual inspection device assembly packaging robotics and material handling.

• Provide technical oversight of PLC/DCS control systems SCADA/HMI batch control machine and motion control vision/inspection systems robotics industrial networks OT infrastructure and interfaces with MES historians and other site systems.

• Review and approve automation engineering work including control strategies functional and design specifications control narratives system architectures interface definitions software/configuration standards FAT/SAT protocols commissioning and qualification documentation and automation change controls.

• Ensure automation work and system lifecycle practices comply with global standards cGMP requirements GAMP 5 expectations data integrity principles cybersecurity controls and applicable validation requirements.

• Support inspections risk assessments investigations deviations corrective and preventive actions and timely remediation activities related to Drug Product automation systems.

• Manage project cost quality schedule scope resources and risk; remove obstacles maintain accurate execution plans and raise key decisions or issues to senior business and project team members as needed.

• Build effective partnerships with Manufacturing Process Engineering Quality Computerized System Validation OT Infrastructure MES BAS and Utilities Lab Systems Procurement Digital and other cross-functional partners.

• Serve as the primary Drug Product automation point of contact for the site and ensure integrated delivery with process equipment digital and manufacturing teams.

• Define monitor and report meaningful metrics and key performance indicators for project delivery system performance compliance reliability and lifecycle health.

• Lead technical selection alignment performance management and delivery governance for automation suppliers OEM controls teams system integrators and automation service providers.

• Ensure supplier designs software and integration work align with site automation architecture standards cybersecurity validation and lifecycle requirements.

• Develop and maintain reusable design standards specifications libraries templates and engineering practices that support consistent maintainable and scalable automation solutions.

• Ensure operational readiness through effective support models training documentation maintenance strategies spare-parts planning disaster recovery business continuity and system ownership arrangements.

• Use industry experience and operational data to identify and lead continuous improvement opportunities across automation validation reliability manufacturing performance and digital enablement.

Qualifications

Education:

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

Experience and Skills:

Required:

• Minimum of 8 years of progressive industrial automation and controls engineering experience in pharmaceutical or biopharmaceutical manufacturing including direct technical ownership for the design implementation commissioning qualification troubleshooting and lifecycle management of automated manufacturing systems in a cGMP environment.

• Demonstrated Drug Product automation experience supporting sterile or aseptic manufacturing operations including formulation aseptic filling/finish optical or visual inspection device assembly packaging robotics or other highly automated Drug Product manufacturing processes.

• Proven leadership experience directing automation and controls engineers technical professionals contractors OEM automation teams suppliers and system integrators with accountability for technical direction resource planning issue resolution and delivery of automation scope.

• Deep technical knowledge of ISA-95 Level 1 and Level 2 manufacturing automation systems including DCS PLC SCADA/HMI batch control machine controls servo/motion control vision and inspection systems robotics industrial networks communication protocols OT infrastructure and related hardware and system interfaces.

• Experience integrating manufacturing automation with Level 3 systems such as MES historian recipe management data platforms and related business or quality systems including interface definition data-flow mapping and troubleshooting across systems.

• Working knowledge of ISA-88 and ISA-95 standards and their application within regulated manufacturing capital project and global supply-chain environments.

• Strong understanding 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.

• Demonstrated automation project execution experience including controls design reviews OEM and system integrator management FAT/SAT commissioning qualification risk management automation change control troubleshooting and start-up support within a complex pharmaceutical manufacturing or capital-project environment.

• Strong communication and stakeholder-management skills with the ability to influence align and partner effectively with Automation Manufacturing Engineering Quality CSV OT Infrastructure Digital project leadership and senior management teams.

• Ability and willingness to support project travel and on-site execution needs across design construction start-up and steady-state phases including travel to supplier OEM system integrator and Johnson & Johnson affiliate sites as required.

• 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:

• Experience with aseptic filling/finish equipment and associated isolator or barrier technologies inspection systems device assembly packaging machinery robotics motion control or other highly automated Drug Product equipment.

• Experience leading the automation scope of a large pharmaceutical capital project from concept and design through controls development construction FAT/SAT commissioning qualification start-up and operational handover.

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

• Project Management Professional certification or equivalent project-management experience.

• Experience with reliability engineering asset lifecycle management operational readiness and maintenance 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 in a global organization and managing multiple suppliers engineering partners and system integrators.

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

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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) Business Alignment Data Integration Developing Others Inclusive Leadership Industry Analysis Innovation Leadership Lean Supply Chain Management Machine Learning (ML) Management Systems Implementation Process Improvements Prototyping Quality Assurance (QA) Robotic Automation Science Technology Engineering and Math (STEM) Application Smart Systems Team Management Workflow Automation