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Production Equipment Specialist

2 months ago

Sacramento, California, United States Orca Bio Full time
Position Overview

At Orca Bio, we are dedicated to transforming the landscape of blood cancer treatment through innovative cell therapies. Our mission is to enhance patient survival rates while minimizing risks associated with traditional transplant methods.

Key Responsibilities
  • The Equipment Engineer will oversee the maintenance and reliability of production and laboratory assets across various sites involved in the creation of clinical and commercial drug products.
  • Provide technical guidance and manage maintenance activities, including both preventative and corrective measures, calibrations, and certifications for essential equipment.
  • Ensure that all equipment operates in compliance with regulatory standards and meets production demands.
Essential Duties
  • Diagnose and rectify equipment performance issues, malfunctions, or failures.
  • Monitor equipment downtime and failure patterns, implementing corrective actions to mitigate future occurrences.
  • Coordinate maintenance, calibration, and certification tasks performed by external service providers.
  • Conduct preventative and corrective maintenance tasks as needed.
  • Review and validate documentation from service providers.
  • Utilize the Computerized Maintenance Management System (CMMS) for task completion and tracking.
  • Maintain production and laboratory assets to meet Good Manufacturing Practice (GMP) standards.
  • Develop and deliver training programs to enhance asset operation and maintenance knowledge.
  • Collaborate with colleagues to continuously improve equipment standards and operational practices.
  • Engage with site teams on new equipment installations and modifications.
  • Lead initiatives aimed at stabilizing and optimizing equipment systems.
  • Participate in small projects and continuous improvement efforts.
  • Perform additional duties as assigned.
Qualifications
  • A Bachelor’s degree in Engineering or Life Sciences is required, along with relevant experience in a GMP manufacturing setting.
  • A minimum of 4 years of experience in a GMP facility, focusing on equipment operation, troubleshooting, and maintenance.
  • Experience with reliability metrics and CMMS is preferred.
Personal Attributes
  • Ability to manage multiple tasks and prioritize effectively.
  • Strong work ethic and eagerness to learn in a dynamic environment.
  • Willingness to support production and quality control outside of regular hours as needed.
  • Excellent interpersonal and communication skills.
  • Strong analytical and problem-solving abilities.
  • Capacity to work in cleanroom environments and follow stringent protocols.
  • Ability to collaborate effectively as part of a team or independently.
  • Adaptability to a fast-paced start-up culture while adhering to established procedures.
  • Proficient in working for extended periods on a computer.
  • Physical capability to navigate the workspace, including occasional stair use.

The anticipated annual salary range for this position is influenced by various factors, including experience, education, and location. Benefits include pre-IPO equity, comprehensive medical, dental, and vision coverage, flexible paid time off, a 401(k) plan, life insurance, and parental leave. Additional perks include complimentary meals and snacks at our facilities.

Company Culture

At Orca Bio, we are driven by a commitment to scientific advancement and patient care. Our core values—passion, courage, and integrity—guide our efforts to improve the quality of life for those we serve. We foster an entrepreneurial spirit, encouraging innovation and challenging conventional approaches.

We are proud to be an equal opportunity employer, recognizing that our diverse perspectives lead to stronger solutions for our team and the patients we support.