Nivagen Pharmaceuticals, Inc.

Nivagen Pharmaceuticals, Inc.

Director, Engineering, Maintenance & Reliability

Sacramento, CA 95834 · Director · Contract

Sponsorship not specifiedDetected 61 days ago
CybersecurityComplianceAccessibilitySupply ChainProcurementManual TestingGMPLeadershipPublic SpeakingSCADA

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Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Files H-1B transfers

7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people.
  • 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.
  • Job Location: Nivagen Pharmaceuticals 3900 Duckhorn Dr, Sacramento, CA 95834.

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.
  • Build technical depth, succession plans, and sustainable internal capability for critical systems while using contractors and OEM support effectively.
  • 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.
  • 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.
  • 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.

Benefits

  • Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
  • 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.

Company info

  • 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.
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