Project Engineer
Job Summary
Independently, or under limited or null supervision, works on complex by nature assignments, which
require considerable criteria, judgment and initiative in order to solve problems and issue
recommendations in attainment with a defined timeline. The project engineer is responsible for
designing, communicating and implementing an operational plan for completing engineering-based
projects. Prepares designs, project controls and specifications, schedules, installation, testing and
commissioning of new equipment, tooling, lines, fixtures, etc. Monitors progress and performance
against the project plan. Identifies, develops and gathers the necessary resources to complete the
project.
Duties and Responsibilities
• Benchmarks and advises leadership on Validation and Technical Transfer supply chain project
plans and key milestones that produce deliverables aligned with customer’s operational needs
and requirements.
• Performs process validations on new and transferred processes/equipment for subsequent
operational integration and supply chain implementation.
• Identifies any non-conformance and subsequent corrective and preventive actions, by
documenting, investigating, and conducting root cause analysis, and successfully
implementing corrective actions.
• Examines outputs of Project Engineering Technicians by supporting and enforcing site-specific
safety and industrial hygiene requirements.
• Identifies and communicates, in a timely manner, any Project Engineering issues or concerns
to the next management level.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day
interactions with team.
• Provides solutions to the problems in manufacturing of current and new models.
• Performs basic operational diagnostics test. Solves problems and disconnects components,
subassemblies and manufacturing systems, processes and equipment with the purpose of
isolating failures, determining the solution and performing the necessary training.
• Starts, adjusts and operates basic laboratory and manufacturing equipment.
• Can provide recommendations and technical support for new projects, process improvements
and quality investigations.
• Follows the Convenient Information Retention Administration Policies of J&J and of the
Campus, record retention program, training and education, Document Retention Notices,
Record cleanup, inactive records and Information Management, Vital Records if applicable.
• Responsible for following all Company guidelines related to Health, Safety and Environmental
practices as applicable.
• For those who supervise or manage staff, they are responsible for ensuring that subordinates
follow all Company guidelines related to Health, Safety and Environmental practices and that
all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and
Company regulations, policies, and procedures.
Experience and Education
• Engineering, any specialty
• Master’s degree, desirable
• Generally, Requires 2-4 Years Work Experience
• Advanced English
• Effective communication in English and Spanish across functions and both
internally/externally
Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations
• Leadership experience.
• Technical and practical ability fundamental for engineering areas applicable to the transfer
project.
• Project management experience.
• Ability for the resolution of failures, in aspects or areas of equipment, and manufacturing
processes.
• Ability to integrate into work groups.
• Knowledge of catheters and Medical device companies.
• Ability to use measuring and testing equipment associated with specific discipline.
• Advance ability to read and understand technical documentation associated with specific
discipline.
• Ability to learn about regulatory requirements (GMP and GDP).
• Ability to use computers and related software.
• Able to work in a Clean Room environment requiring gowning.
• Must have strong communication and interpersonal skills and be able to support cross
functional teams including Quality, Operations & Engineering.