Staff Manufacturing Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity.

About the Role

Johnson & Johnson Med Tech is recruiting for a Staff Manufacturing Engineer located in Añasco, Puerto Rico. This role will handle most aspects of projects or initiatives, providing advanced engineering, design, and construction of manufacturing facilities, systems, and equipment. You will also provide engineering and technical support for complex production and processing equipment, manage problem identification, reporting, root cause analysis, project management, financial analysis, efficiency or productivity improvement, and problem resolution. The role interfaces directly with other departments, sites, and corporate functional groups to drive and/or support critical business goals/objectives within GMP/ISO compliance.

Under the direction of the Engineering Manager, you will lead and support continuous improvement activities to ensure business key performance indicators are met, and lead groups of Engineers or Technicians on projects or special assignments.

Responsibilities

• Develops process excellence techniques to identify systematic issues.
• Tracks trends, develops, and implements equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability.
• Leads and executes projects and/or programs of moderate to high level of complexity ensuring safety, regulatory compliance, company standards, operation requirements, and business needs.
• Provides technical support to peers and production areas in evaluating process deficiencies, process changes, modifications, and process optimization.
• Defines, analyzes, reviews, and evaluates problems for prompt solutions.
• Sets the engineering standard and direction for the group and is recognized as the source for mentorship in a field.
• Reviews evaluations and advises on the selection of suitable equipment for optimized, balanced line performance, making final recommendations to management.
• Prepares project estimates for design, equipment, installation, labor, materials, and other related costs; prepares project forecasts, schedules, and tracks costs.
• Challenges the “status quo” on a routine basis and develops new ideas within incoming processes.
• Drives phases of work with different site functions and with other divisions.
• Provides technical support for Non-conformance issues in the manufacturing area, generating investigation reports and corrective action identification (coordinates and participates in Multi-functional Investigations).
• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies, and Federal, State, and Local Government Regulations.
• Writes, develops, and executes validation strategies.
• Works independently, plans, and develops own methods, takes actions in the absence of specific instructions, and develops and presents new or improved methods.
• Solves manufacturing problems in a timely manner.
• Stays in sync with all environmental, safety, and occupational health policies.

Requirements

• Bachelor’s Degree in Engineering.
• Minimum of 6 years of experience in a maintenance manufacturing environment, R&D, or Process Development.
• Demonstrated experience in Project Management.
• Proven experience with the validation cycle (FAT, IQ, OQ, and PQ).
• Must be fully bilingual: Spanish & English.
• Proficiency with Microsoft Office: Word, Excel, PowerPoint.

Skills

• Preferred Skills:
  • Experience with data analysis tools: Minitab.
  • Experience working in the medical device industry or pharmaceutical industry.

This position will require up to 10% travel and is fully onsite.