Director, Aseptic Eng. & Reliability – Sacramento

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

Benefits offered by this job

Medical, dental, and vision benefits

Sick Time/PTO

Yearly bonus eligibility

Job summary

Nivagen Pharmaceuticals in Sacramento requires a Director of Engineering, Maintenance & Reliability to lead aseptic manufacturing assets, ensure regulatory compliance, and drive reliability across site operations. This role oversees process engineering, automation, maintenance execution, reliability, capital projects, and asset lifecycle management to sustain high-quality, compliant production.

The leader partners with Manufacturing, Quality Assurance, Validation, Sterility Assurance, EHS, IT,

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical/Controls Engineering, or related field.
• Minimum 12 years of progressive engineering, maintenance, reliability, or operations experience in pharmaceutical manufacturing.
• Minimum 5 years of leadership experience managing multidisciplinary teams.
• Experience supporting sterile/aseptic manufacturing operations.
• Experience with isolators, RABS, aseptic filling equipment, and hygienic process systems.
• Experience leading capital projects and managing budgets.

Responsibilities

• Lead the site Engineering, Maintenance, and Reliability organization with GMP asset ownership.
• Oversee maintenance, reliability, automation/OT, capital projects, and lifecycle management for aseptic equipment.
• Drive improvements to equipment availability, sterility, and data integrity without compromising quality.
• Ensure compliance with cGMP, validation, change control, and quality systems in all activities.
• Develop technical ownership, escalation paths, and qualification standards; build internal capability.
• Partner with QA, Validation, Sterility Assurance, IT, Finance, and corporate engineering to meet production goals.

Skills

Leadership

Engineering leadership

Regulatory compliance

Aseptic manufacturing

Capital projects

Asset lifecycle

OT/Automation

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Electrical/Controls Engineering

Job description

Nivagen Pharmaceuticals in Sacramento requires a Director of Engineering, Maintenance & Reliability to lead aseptic manufacturing assets, ensure regulatory compliance, and drive reliability across site operations. This role oversees process engineering, automation, maintenance execution, reliability, capital projects, and asset lifecycle management to sustain high-quality, compliant production.

The leader partners with Manufacturing, Quality Assurance, Validation, Sterility Assurance, EHS, IT,