Staff Manufacturing Engineer

Johnson & Johnson Innovative Medicine•Añasco, PR
•Onsite

About The Position

Johnson & Johnson is seeking a Staff Manufacturing Engineer for its Vision team in Anasco, Puerto Rico. The role focuses on improving manufacturing processes and equipment to increase efficiency, product yield, and reliability while meeting safety, regulatory, company, operational, and business requirements. The engineer leads projects of moderate to high complexity, provides technical support to production and peers, evaluates process deficiencies and changes, and recommends equipment and process improvements. The position also provides technical leadership and mentorship, manages project estimates, forecasts, schedules, and costs, supports manufacturing non-conformance investigations and corrective actions, and develops and executes validation strategies. The engineer works independently, develops methods and solutions, follows SOPs, GMPs, company policies and applicable regulations, and complies with environmental, safety, and occupational health policies. The position requires up to 10% travel and is fully onsite.

Requirements

  • Bachelor’s degree in Engineering.
  • At least 6 years of experience in a maintenance manufacturing environment, R&D, or Process Development.
  • Demonstrated project management experience.
  • Experience with the validation cycle, including FAT, IQ, OQ, and PQ.
  • Full bilingual proficiency in Spanish and English.
  • Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Nice To Haves

  • Experience with data analysis tools such as Minitab.
  • Experience in the medical device or pharmaceutical industry.

Responsibilities

  • Develop process-excellence techniques to identify systematic issues; track trends and implement equipment or process enhancements to improve efficiency, product yield, and equipment reliability.
  • Lead and execute projects or programs of moderate to high complexity while ensuring safety, regulatory compliance, company standards, operational requirements, and business needs.
  • Provide technical support to peers and production areas by evaluating process deficiencies, process changes, modifications, and optimization opportunities; analyze problems and develop prompt solutions.
  • Set engineering standards and direction for the group, mentor others, review equipment evaluations, and make final equipment recommendations to management for optimized, balanced line performance.
  • Prepare project estimates covering design, equipment, installation, labor, materials, and related costs; prepare forecasts and schedules and track project costs.
  • Challenge existing processes and develop new ideas for incoming processes.
  • Drive phases of work with site functions and other divisions.
  • Provide technical support for manufacturing non-conformance issues, including investigation reports and corrective-action identification; coordinate and participate in multifunctional investigations.
  • Follow SOPs, GMPs, company policies, and applicable federal, state, and local regulations.
  • Write, develop, and execute validation strategies.
  • Work independently, plan and develop methods, act in the absence of specific instructions, present new or improved methods, and solve manufacturing problems in a timely manner.
  • Comply with environmental, safety, and occupational health policies.
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