Director, Engineering, Maintenance & Reliability

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. **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:** **1. 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 OEM support effectively. - Promote a culture of safety, quality, disciplined execution, timely escalation, continuous improvement, and proactive risk management. **2. Aseptic Manufacturing Equipment** - 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. **3. Formulation, Compounding, and Sterile Filtration Systems** - 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. **4. Maintenance Management** - 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. **5. Reliability Engineering** - 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. **6. Automation and Operational Technology** - 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. **7. Capital Projects and Asset Lifecycle Management** - 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. **8. Compliance and Quality Systems** - 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. **9. Operational Excellence and Performance Improvement** - 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. **10. Financial, Vendor, and Resource Management** - 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. **Supervisory Responsibilities** This position has direct supervisory responsibility for leaders and individual contributors within Engineering, Maintenance, Reliability, Automation/OT, Facilities and Utilities, Calibration/Metrology, and Capital Projects, as assigned. The position is also responsible for technical direction of contractors, vendors, OEM personnel, and project teams. **Leadership Expectations** - Place patient safety, product quality, sterility assurance, and personnel safety at the center of engineering decisions. - Maintain a visible presence in manufacturing and regularly observe equipment operation and maintenance work at the point of execution. - Demonstrate calm, decisive technical judgment during operational disruptions, quality events, and major equipment failures. - Communicate technical issues, operational consequences, options, and business risks clearly to senior leadership. - Create accountability while encouraging timely escalation and transparent reporting of risk. - Build trusted partnerships across Manufacturing, Quality, Validation, Sterility Assurance, EHS, Supply Chain, Finance, IT, and corporate functions. - Move the organization from reactive maintenance toward proactive reliability, defect elimination, and lifecycle management. - Develop people and sustainable technical capability rather than relying excessively on individual experts, contractors, or vendors. **Non-Essential Functions** - 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. **Education/Experience:** - Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Controls Engineering, or a related technical discipline required. - Advanced degree in engineering, operations, business administration, or a related discipline preferred. - 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. **Required Knowledge, Skills, and Abilities** - 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. **Preferred Qualifications:** - 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. **Physical Requirements/ Working Conditions:** - Ability to sit, stand, walk, bend, reach, and climb stairs or ladders as needed to support manufacturing, utility, and engineering activities. - Ability to work at a computer workstation and participate in meetings for extended periods. - Ability to enter cleanrooms, manufacturing suites, packaging areas, warehouses, mechanical spaces, utility areas, and equipment rooms. - Ability to wear required PPE and cleanroom gowning when supporting classified areas. - Ability to visually inspect equipment, utilities, documentation, process conditions, and computer displays. - Ability to lift, carry, push, or pull items up to 25 pounds as needed. - Ability to work overtime, weekends, holidays, shutdowns, alternative hours, or on-call support as business needs require. **Work Environment** - Work is performed in a GMP pharmaceutical manufacturing facility, including offices, cleanrooms, manufacturing suites, packaging areas, laboratories, equipment rooms, utility spaces, and warehouses. - The role may require entry into Grade A, B, C, D, and controlled support areas depending on process and production needs. - Work may occur near operating equipment, automated machinery, pressurized systems, sterilants, disinfectants, production materials, controlled temperatures, and cleanroom environments. - Strict adherence to GMP, safety, gowning, hygiene, contamination-control, data-integrity, and documentation procedures is required. - This position requires regular on-site presence; limited remote work may be possible depending on business needs and company policy. **Schedule / Shift Requirements** - Standard business hours are typical, but support outside normal hours is required based on production, project, shutdown, or emergency needs. - Overtime, weekends, holidays, shutdown coverage, and on-call availability may be required. - Must be able to respond to urgent equipment, facility, utility, automation, quality, and supply-continuity issues. **Requirements:** - 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) **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 **Additional Information:** Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.