Manufacturing Engineering Manager: Lead High-Impact GMP/ISO Ops

Johnson Johnson; Añasco (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson Med Tech is seeking a Manufacturing Engineer Manager in Añasco, Puerto Rico to lead a team of manufacturing engineers and drive process improvements in a GMP/ISO regulated environment. The role interfaces with Operations, Quality, Maintenance, Automation, Facilities, and Supply Chain to align priorities and deliver robust manufacturing solutions.

The successful candidate will bring 8+ years of manufacturing engineering leadership, hands-on experience with validation

Qualifications

• Bachelor's Degree in Engineering is required; advanced degree or business/operations leadership training is preferred.
• Minimum of 8 years of relevant experience in manufacturing engineering, maintenance manufacturing, process development, R&D, automation, or regulated manufacturing operations is preferred.
• People leadership or demonstrated technical/team leadership experience is required; experience developing engineers, managing priorities, and leading through influence is strongly preferred.
• Experience in the medical device or pharmaceutical industry is preferred.
• Demonstrated experience in project management, financial management, resource planning, and presentation of business cases or CARs is preferred.
• Demonstrated experience with GMP/ISO requirements, validation lifecycle, FAT, IQ, OQ, PQ, process characterization, and technical investigations is preferred.
• Experience with optical inspection systems, automated equipment, design reviews with vendors, and equipment/process optimization is preferred.
• Strong communication, cross-functional collaboration, decision-making, coaching, and stakeholder management skills are required.

Responsibilities

• Lead, coach, and develop the Manufacturing Engineering team, ensuring proper span of control, clear priorities, accountability, and effective leadership routines that support engagement, retention, and talent development.
• Establish engineering standards, direction, and governance for manufacturing areas, ensuring effective line-side support, technical escalation, and structured problem solving across value streams.
• Drive operational performance metrics including yield, UPPH, uptime, OEE, process reliability, and productivity through disciplined engineering execution, trend analysis, and risk-based prioritization.
• Lead and execute programs and projects of moderate to high complexity, ensuring safety, regulatory compliance, company standards, operational requirements, financial discipline, and business needs are achieved.
• Provide leadership for root cause analysis, non-conformance investigations, corrective and preventive actions, process characterization, process control improvements, and complex production or processing equipment support.
• Ensure validation strategies and execution are robust, including FAT, IQ, OQ, PQ, computer systems validation where applicable, design reviews, and readiness for regulated manufacturing implementation.
• Build sustainable systems for resource planning, workload management, and project prioritization across day-to-day operations, strategic initiatives, and long-term process improvement work.
• Partner cross-functionally with Operations, Quality, Maintenance, Automation, Facilities, Supply Chain, Finance, Human Resources, Talent Acquisition, and global engineering to align business needs, staffing plans, and execution deliverables.
• Prepare and present business cases, CARs, project estimates, schedules, forecasts, resource plans, and status updates to support timely decisions and leadership alignment.
• Challenge the status quo and promote continuous improvement, technical excellence, standard work, and proactive risk identification across the manufacturing engineering organization.
• Support staffing governance by ensuring roles have clear business justification, impact assessment, role expectations, equivalent pay grade alignment, and required approvals before filling positions.
• Ensure adherence to Standard Operating Procedures, Good Manufacturing Practices, company policies, environmental, safety, occupational health, and applicable federal, state, and local regulations.

Skills

People leadership

Project management

Cross-functional collaboration

Regulatory compliance

Problem solving

Strong communication

Decision-making

Education

Bachelor's Degree in Engineering

Advanced degree or leadership training preferred

Tools

Validation lifecycle tools

Job description

Johnson & Johnson Med Tech is seeking a Manufacturing Engineer Manager in Añasco, Puerto Rico to lead a team of manufacturing engineers and drive process improvements in a GMP/ISO regulated environment. The role interfaces with Operations, Quality, Maintenance, Automation, Facilities, and Supply Chain to align priorities and deliver robust manufacturing solutions.

The successful candidate will bring 8+ years of manufacturing engineering leadership, hands-on experience with validation