Automation Engineering Manager, Drug Product Manufacturing Lead

Johnson & Johnson Innovative Medicine•Wilson, NC

5d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

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.