Director, Engineering, Maintenance & Reliability

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Nivagen Pharmaceuticals, Inc. in Sacramento seeks a Director of Engineering, Maintenance & Reliability to lead the site’s aseptic manufacturing assets, automation and OT, and maintenance programs.

The role drives safety, quality, compliance and cost management while ensuring reliable equipment and validated processes in a highly regulated environment. The successful candidate will build and sustain a high-performance organization across engineering, maintenance, reliability, capital projects,

Job description

About the Company

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

About the Company

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location

Nivagen Pharmaceuticals

3900 Duckhorn Dr, Sacramento, CA 95834.

About the Job

The Director of Engineering, Maintenance & Reliability is accountable for the technical performance, compliance, reliability, and lifecycle management of the site's aseptic manufacturing assets, and operational technology. The operation manufactures sterile liquid products in multiple presentations, including prefilled syringes, vials, and preformed bags, using isolators, Restricted Access Barrier Systems (RABS), formulation and filtration tanks, aseptic filling and sealing equipment, classified cleanrooms, and critical utilities.

This leader builds and directs the organization responsible for manufacturing and process engineering, automation and operational technology, maintenance execution, reliability engineering, capital projects, and asset lifecycle and obsolescence management.

The Director ensures that equipment, automation, and maintenance practices remain safe, reliable, qualified, validated, inspection-ready, and capable of meeting production requirements. The role partners closely with Manufacturing, Quality Assurance, Validation, Sterility Assurance, Microbiology, Environmental Health and Safety, Supply Chain, Information Technology, Finance, and corporate engineering.

This position requires a leader who can balance patient safety, product quality, sterility assurance, regulatory compliance, equipment availability, operational performance, and cost management in a highly regulated aseptic manufacturing environment.

Responsibilities

• Engineering Leadership and Organizational Development
• Lead the site Engineering, Maintenance, and Reliability organization and establish clear accountability for GMP-critical assets and systems.
• Develop an organizational structure that provides effective ownership of aseptic filling and packaging equipment, isolators and RABS, formulation and filtration systems, cleanrooms and HVAC, clean utilities, automation and OT systems, maintenance, reliability, calibration, and capital projects.
• Recruit, develop, coach, and retain engineers, maintenance technicians, reliability professionals, automation specialists, planners, supervisors, and technical subject-matter experts.
• Define technical ownership, escalation paths, decision rights, performance expectations, training requirements, and qualification standards.
• Build technical depth, succession plans, and sustainable internal capability for critical systems while using contractors and