EQUIPMENT ENGINEER II - (BILINGUAL) (TEMPORARY 12 MONTHS)

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• Provides technical expertise and assistance to assigned engineers, manufacturing associates, supervisors and technicians during line design, installation and monitoring to ensure a flawless ramp up of production launches.

• Evaluates and implements new automation technologies into manufacturing operations; designs, selects, and installs hardware and software upgrades.

• Executes specific automation-related capital projects from design through construction, equipment concept validation and approval.

• Disposal management of production line assets.

• Coaches project management teams in the identification of scope changes, including provision of necessary information to support claims for time and cost impact.

• Leads capital management initiatives, including cost estimating, schedule development, cost-benefit analysis, and technical fitment evaluations.

• Develops and executes detailed project plans using standard project management tools (charters, Gantt charts, etc.).

• Responsible for communicating business-related issues or opportunities to the next management level.

• Supports the evaluation of business plans for project portfolio prioritization.

• Responsible for following and coaching teams on all Company guidelines related to Health, Safety and Environmental practices, as applicable.

• For positions with supervisory responsibilities, ensures that subordinates comply with all Company Health, Safety and Environmental guidelines and that the necessary resources are available and maintained in good condition.

• Manages individual and multiple complex projects simultaneously.

• Conducts complex assessments to determine regulatory compliance and identify necessary improvements to meet regulatory requirements.

• Executes the NCR and CAPA processes by documenting, investigating, performing root cause analysis, and implementing corrective and preventive actions for product non-conformances.

• Creates and updates documentation as required to enhance and adapt quality and manufacturing systems to business needs.

• Demonstrates high proficiency in validation strategy and execution, delivering consistent results in equipment implementation and/or process improvements.

Equipment Engineering Specialties

The Equipment Engineer supports multiple business areas and, depending on the role, responsibilities may be adjusted to meet strategic business needs, including Critical Equipment, Proactive Engineering and Projects Engineering.

Critical Equipment

• Troubleshoots and tests new equipment.

• Monitors and analyzes data to identify potential issues or opportunities for improvement.

• Maintains and administers manufacturing equipment control systems in support of daily process operations.

• Executes machine and process improvements on automation systems post-release to support operational objectives such as yield, uptime and reliability.

• Writes and reviews documentation, including procedures, special instructions, qualification plans and reports, and corrective action plans.

• Ensures safe working conditions and practices within the department and supports compliance with plant safety requirements.

• Participates as a project implementation team member and provides manufacturing support for systems directly interconnected with equipment.

Proactive Engineering

• Ensures regulatory compliance through validation and verification processes.

• Determines processes requiring validation, develops plans and analysis criteria, executes validation activities, and performs final analysis and acceptance.

• Establishes governance for ongoing quality actions, monitoring and appropriately communicating potential implementation risks.

• Facilitates CAPA and non-conformance meetings and prepares investigation documentation associated with manufacturing compliance issues.

• Performs investigations and root cause analyses to identify solutions and necessary corrective and preventive actions.

• Executes investigation processes from initiation to closure, including stakeholder identification, timeline development, escalation and change management.

• Creates or updates manufacturing procedures and documentation to incorporate process improvements.

• Identifies and eliminates potential compliance gaps in manufacturing processes and documentation.

• Provides training and support to ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including implementation of related actions.

• Provides support during internal and external audits.

• Develops strategies and implementation plans for compliance-related matters.

• Collaborates with and influences Quality, Engineering and Manufacturing departments to ensure consistency and effective execution of key quality systems.

• Performs process and equipment validations, including IQ/OQ/PQ and software validation activities, for equipment, materials and tools used in manufacturing processes.

• Monitors and improves actions while ensuring quality and cost-effective execution.

Projects Engineering

• Supports capacity increase projects, including new line installations, validations, line reconfigurations and Lean deployment initiatives.

• Supports technology transfer activities and equipment validation.

• Ensures Environmental Health & Safety (EH&S) and compliance requirements are met during existing and new project or line deployments.

• Creates and drives validation strategies for new and existing manufacturing equipment.

• Creates, updates and maintains manufacturing procedures related to processes, equipment, and compliance documentation.

• Executes line and equipment decommissioning projects to enable additional manufacturing capacity at the site.

• Establishes flexibility and decommissioning strategies, defines deliverables and timelines, and ensures adherence to project deadlines.