Director, Engineering, Maintenance & Reliability

Nivagen Pharmaceuticals • Sacramento, CA

19h • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Controls Engineering, or a related technical discipline required.
• Minimum of 12 years of progressive engineering, maintenance, reliability, automation, facilities, or technical operations experience in pharmaceutical, biotechnology, medical device, or another highly regulated manufacturing environment preferred.
• Minimum of 5 years of leadership experience managing multidisciplinary technical teams preferred.
• Demonstrated experience supporting sterile or aseptic manufacturing operations.
• Experience with isolators, RABS, aseptic filling equipment, formulation and filtration tanks, hygienic process systems, cleanrooms, critical utilities, or automated manufacturing systems.
• Experience leading capital projects and managing operating and capital budgets.
• Demonstrated success improving equipment reliability, maintenance performance, compliance, manufacturing capacity, or organizational capability.
• Strong understanding of aseptic manufacturing, contamination control, cGMP requirements, qualified facilities and utilities, and validated manufacturing systems.
• Working knowledge of maintenance planning and scheduling, preventive and predictive maintenance, reliability engineering, calibration, asset criticality, and spare-parts management.
• Ability to lead structured investigations and apply root cause analysis, FMEA, risk assessment, and defect-elimination methods.
• Understanding of PLC, HMI, SCADA, computerized equipment, data historians, OT support, configuration control, and industrial cybersecurity principles.
• Strong capital planning, project governance, vendor management, financial management, and resource prioritization skills.
• Ability to interpret manufacturing, downtime, maintenance, alarm, quality, and cost data and translate findings into action.
• Excellent leadership, coaching, executive communication, cross-functional influence, and change-management skills.
• Ability to work effectively on the manufacturing floor and provide support during critical operational events.
• Must have experience in Pharmaceutical Manufacturing
• Valid driver’s license and acceptable driving record
• Legally authorized to be employed in the United States
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles’ radius)

Nice To Haves

• Advanced degree in engineering, operations, business administration, or a related discipline preferred.
• Master’s degree in engineering, operations, business administration, or a related discipline.
• Professional Engineer license, Certified Maintenance and Reliability Professional certification, project management certification, or equivalent technical credential.
• Direct experience with multiple sterile presentations, particularly prefilled syringes, vials, and preformed bags.
• Experience with vaporized hydrogen peroxide decontamination systems, isolator cycle development, glove integrity systems, and barrier leak testing.
• Experience with formulation, compounding, sterile filtration, clean-in-place, steam-in-place, hygienic piping, and single-use systems.
• Knowledge of ASME BPE principles and sterile manufacturing facility design.
• Experience implementing reliability-centered maintenance, predictive maintenance, and condition-monitoring programs.
• Experience supporting regulatory inspections and customer audits in an aseptic manufacturing facility.
• Experience designing, building, or scaling an Engineering, Maintenance, and Reliability organization.

Responsibilities

• 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 OEM support effectively.
• Promote a culture of safety, quality, disciplined execution, timely escalation, continuous improvement, and proactive risk management.
• Provide technical leadership and lifecycle ownership for syringe, vial, and preformed bag filling and closure systems; isolators; RABS; decontamination systems; component handling; inspection; leak testing; and associated support equipment.
• Ensure equipment design, operation, maintenance, and modification support aseptic processing requirements and the site Contamination Control Strategy.
• Drive reduction of equipment-related interventions, contamination risks, recurring failures, minor stops, rejects, and changeover losses within critical aseptic operations.
• Establish technical strategies for barrier pressure control, glove integrity testing, isolator leak testing, decontamination-cycle performance, transfer systems, alarms, interlocks, and equipment recovery following intrusive maintenance.
• Ensure maintenance methods protect critical surfaces, HEPA filters, glove systems, pressure boundaries, sterile pathways, and decontamination capability.
• Improve filling-line availability, throughput, yield, and reliability without compromising sterility assurance, product quality, data integrity, or validated operation.
• Provide engineering ownership for formulation, compounding, hold, and filtration systems, including stainless-steel tanks, agitation, load cells, temperature control, transfer piping and hoses, filters, vents, and associated instrumentation.
• Ensure hygienic design, cleanability, sterilizability, drainability, material compatibility, and maintainability of product-contact systems.
• Partner with Process Engineering, Manufacturing, Quality, Validation, and Sterility Assurance to maintain control of mixing parameters, hold times, product temperature, sterile filtration conditions, filter integrity testing, and aseptic transfers.
• Provide technical oversight for clean-in-place, steam-in-place, single-use assemblies, sterile connectors, and product-contact change parts, where applicable.
• Lead or support investigations involving mixing variability, filter failures, integrity-test failures, equipment residues, tank or piping contamination, transfer losses, and other process-equipment issues.
• Own the site maintenance program for GMP and non-GMP assets, including preventive, predictive, condition-based, corrective, and emergency maintenance.
• Establish disciplined planning and scheduling, job plans, work-order prioritization, weekly scheduling, shutdown planning, backlog management, kitting, spare-parts control, and maintenance standard work.
• Improve schedule compliance and planned-work percentage while reducing reactive and emergency maintenance.
• Ensure maintenance work protects product, cleanroom classification, contamination controls, qualified systems, and validated state.
• Define requirements for equipment cleaning, disinfection, inspection, line clearance, functional testing, documentation, and release following maintenance.
• Establish controls for tools, lubricants, replacement parts, temporary repairs, foreign-material risks, and work within classified or product-contact areas.
• Ensure maintenance records are complete, accurate, timely, attributable, and inspection-ready.
• Manage maintenance contractors and service providers in accordance with site safety, quality, security, and contamination-control requirements.
• Develop and execute a site reliability strategy for manufacturing equipment, facilities, utilities, instrumentation, and automation.
• Establish asset criticality based on patient safety, product quality, sterility assurance, regulatory compliance, personnel safety, production continuity, and business impact.
• Apply reliability-centered maintenance, failure modes and effects analysis, root cause analysis, bad-actor analysis, condition monitoring, defect elimination, and critical-spares analysis.
• Identify chronic failures and implement permanent engineering solutions rather than repeated short-term repairs.
• Lead equipment health reviews and reliability improvement plans for critical systems using downtime, failure, alarm, intervention, and maintenance-history data.
• Manage lifecycle and obsolescence risks for PLCs, control hardware, instrumentation, isolator components, filling systems, utilities, and long-lead assets.
• Develop business continuity, recovery, and contingency plans for failures that could interrupt sterile manufacturing.
• Provide governance and technical leadership for PLCs, HMIs, SCADA, building management systems, data historians, environmental and facility monitoring interfaces, equipment recipes, alarms, and interlocks.
• Establish clear ownership and support models across Engineering, Automation, Quality, Validation, Information Technology, and equipment vendors.
• Ensure automation systems remain secure, supported, backed up, recoverable, appropriately accessed, and maintained under configuration and change control.
• Manage automation lifecycle, software and firmware obsolescence, backups, disaster recovery, patching, user access, and system documentation.
• Partner with IT and cybersecurity resources to maintain appropriate OT network architecture and cybersecurity controls without compromising safety, uptime, or validated operation.
• Ensure changes to control logic, recipes, alarms, interlocks, interfaces, and user access are assessed, tested, approved, documented, and validated as required.
• Develop and execute the site capital plan for capacity, compliance, reliability, obsolescence, safety, sustainability, and cost improvement.
• Translate operational needs into user requirements, concepts, project scopes, schedules, budgets, and business cases.
• Provide technical oversight through feasibility, design, procurement, FAT, SAT, installation, commissioning, qualification, handover, and performance verification.
• Ensure new equipment and modifications incorporate aseptic design, contamination control, hygienic design, maintainability, reliability, safe access, automation, and cybersecurity requirements.
• Engage Engineering and Maintenance early in project design to prevent difficult-to-operate, difficult-to-maintain, or unreliable systems.
• Manage project risks, vendors, technical deliverables, cost, schedule, and turnover requirements, including documentation, spare parts, training, maintenance plans, calibration, and system ownership.
• Ensure engineering and maintenance activities comply with cGMP requirements, approved procedures, specifications, regulatory commitments, and company quality systems.
• Maintain facilities, utilities, equipment, instrumentation, and automation systems in their qualified and validated state.
• Ensure effective execution of change controls, deviations, investigations, CAPAs, engineering assessments, risk assessments, periodic reviews, and maintenance and calibration documentation.
• Partner with Quality, Validation, Manufacturing, Microbiology, and Sterility Assurance on events that may affect product quality or aseptic control.
• Provide engineering support during aseptic process simulations and evaluate equipment-related interventions, alarms, failures, and atypical events.
• Represent Engineering and Maintenance during regulatory inspections, customer audits, and internal audits.
• Ensure observations, commitments, and CAPAs are addressed thoroughly, technically, and on schedule.
• Establish performance metrics and management routines for Engineering, Maintenance, Reliability, Automation, Utilities, and Calibration.
• Reduce unplanned downtime, chronic minor stops, equipment interventions, repeat failures, maintenance-related deviations, excessive changeover time, and utility excursions.
• Use operational, quality, automation, and maintenance data to identify trends, prioritize risk, and target improvement resources.
• Partner with Manufacturing to improve overall equipment effectiveness while protecting aseptic control and validated operation.
• Implement tiered accountability, visual management, standard work, structured problem-solving, and effective escalation.
• Evaluate predictive maintenance, condition monitoring, remote diagnostics, and equipment-data analytics where they provide appropriate value.
• Develop and manage Engineering and Maintenance operating budgets and long-range capital and asset lifecycle forecasts.
• Optimize the mix of internal resources, OEM support, service agreements, contractors, and third-party technical services.
• Evaluate total cost of ownership when making equipment, replacement, spare-parts, service, and staffing decisions.
• Establish governance and performance expectations for critical equipment vendors and service providers.
• Identify cost and productivity improvements without increasing safety, quality, contamination, compliance, reliability, or supply risk.
• Support network and corporate engineering initiatives, technical standards, due diligence, and benchmarking activities.
• Participate in Lean, 5S, sustainability, energy-management, and operational-excellence programs.
• Prepare technical presentations, budget proposals, risk summaries, and management updates.
• Perform other duties as assigned based on business needs.

Benefits

• Competitive Salary: Based on Experience
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage
• Sick Time/PTO

What This Job Offers

• Job Type: Full-time
• Career Level: Director