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Director, Technical Operations & Engineering

Job Profile Summary

The Director, Technical Operations & Engineering provides strategic leadership and oversight for all engineering, maintenance, reliability, automation, validation, utilities, and technical operations activities supporting a rapidly expanding, multiproduct advanced therapies manufacturing site. This role is accountable for ensuring the site's facilities, utilities, equipment, automation systems, and validation programs are designed, installed, qualified, maintained, and continuously improved to support clinical and commercial manufacturing operations.

The Director serves as a key member of the site leadership team and is responsible for developing and executing the long-term technical strategy required to support site growth, technology transfers, capacity expansion, and operational excellence. This includes oversight of GMP and non-GMP assets, facility infrastructure, critical utilities, equipment lifecycle management, vendor and contractor management, inspection readiness, and organization capability development.

Leading a multidisciplinary organization of managers, engineers, validation professionals, automation specialists, and maintenance teams, the Director drives operational reliability, compliance, innovation, and workforce development while fostering a culture aligned with Johnson & Johnson's Credo and Leadership Imperatives.

Key Responsibilities

Strategic Leadership

• Develop and execute the site's Technical Operations and Engineering strategy to support a growing multiproduct manufacturing portfolio, future capacity expansion, and evolving business needs.

• Partner with Site Leadership, Manufacturing, Quality, Supply Chain, MSAT, EHS, and Global Engineering organizations to establish long-range facility, asset, and infrastructure roadmaps.

• Lead engineering and technical readiness activities required to support new product introductions, process changes, technology transfers, and facility expansions.

• Drive continuous improvement initiatives focused on reliability, productivity, asset utilization, sustainability, and operational excellence.

Engineering, Facilities & Utilities

• Provide leadership for engineering programs supporting manufacturing equipment, facilities, automation, and critical utilities.

• Ensure robust lifecycle management of GMP and non-GMP assets, including design, commissioning, qualification, maintenance, reliability, replacement planning, and decommissioning.

• Oversee infrastructure supporting manufacturing operations, including HVAC, clean utilities, process utilities, facility systems, and supporting non-GMP equipment.

• Lead capital project execution associated with capacity expansion, equipment installation, facility modifications, and infrastructure upgrades.

Validation, Qualification & Automation

• Provide strategic oversight of commissioning, qualification, and validation programs including equipment, facilities, utilities, computerized systems, and automation platforms.

• Ensure validation strategies remain compliant, risk-based, and scalable to support a dynamic multiproduct manufacturing environment.

• Lead automation and digital technology strategies to improve operational effectiveness, data integrity, system reliability, and manufacturing performance.

• Partner with global and site stakeholders to drive modernization initiatives and future-state manufacturing technologies.

Maintenance & Reliability

• Establish and maintain world-class reliability and maintenance programs that maximize equipment uptime, manufacturing readiness, and asset performance.

• Implement predictive, preventive, and reliability-centered maintenance strategies.

• Develop key performance indicators and asset management systems to drive continuous improvement and operational excellence.

• Ensure engineering and maintenance resources are aligned to meet current and future manufacturing demands.

Quality & Inspection Readiness

• Accountable for maintaining a state of continuous inspection readiness across engineering, maintenance, validation, automation, and utility operations.

• Ensure compliance with cGMP, regulatory, corporate, and safety requirements.

• Serve as a primary representative during internal audits, health authority inspections, customer audits, and compliance assessments.

• Lead remediation efforts, CAPA execution, and sustainable compliance improvements as required.

Vendor & Contractor Management

• Develop and execute a comprehensive vendor management strategy supporting engineering services, maintenance providers, equipment suppliers, automation partners, and contract resources.

• Establish governance processes to ensure supplier performance, quality, business continuity, and cost effectiveness.

• Lead contract negotiations, supplier evaluations, service-level management, and strategic partnerships.

• Ensure external resources operate in accordance with safety, quality, compliance, and site expectations.

People Leadership

• Lead, coach, and develop a high-performing organization consisting of engineering, maintenance, automation, validation, and technical operations professionals.

• Build organizational capability to support current operations and future business growth.

• Drive succession planning, talent development, workforce planning, and employee engagement initiatives.

• Foster an inclusive, collaborative culture focused on accountability, innovation, continuous learning, and operational excellence.

Scope & Complexity

• Member of the Site Leadership Team with direct impact on manufacturing performance, compliance, and growth strategy.

• Leads a multidisciplinary organization consisting of managers, supervisors, engineers, validation specialists, maintenance professionals, and automation experts.

• Accountable for technical oversight of manufacturing facilities, utilities, infrastructure, automation platforms, validation programs, and engineering systems.

• Supports a complex multiproduct manufacturing environment spanning clinical and commercial operations.

• Manages significant operating and capital budgets and influences strategic investment decisions.

• Interfaces regularly with senior leadership, global functional partners, regulatory agencies, suppliers, and external stakeholders.

Critical Competencies

• Strategic Leadership

• Technical Operations Excellence

• Engineering & Reliability Management

• Validation & Compliance Expertise

• Capital Project Leadership

• Automation & Digital Transformation

• Vendor & Contractor Management

• Organizational Development

• Change Leadership

• Financial Acumen

• Inspection Readiness

• Risk Management

• Influence & Stakeholder Management

• Talent Development & Coaching

Qualifications

• Bachelors degree in Engineering or an equivalent technical discipline is required; Mechanical, Electrical, Chemical, Automation, or a related field is preferred.

• Minimum of 10 years of progressive experience in engineering, technical operations, maintenance, reliability, validation, automation, facilities, utilities, or a related function within a regulated manufacturing environment.

• Demonstrated people-leadership experience managing multidisciplinary technical teams and leaders, with accountability for complex GMP operations, capital and operating budgets, external partners, and strategic technical programs supporting a multiproduct manufacturing site or network.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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