Production Equipment Specialist
2 weeks ago
At Orca Bio, we are committed to transforming the landscape of blood cancer treatment through innovative cell therapies. Our mission is to enhance survival rates while minimizing risks associated with traditional transplant methods.
Key ResponsibilitiesThe Equipment Engineer plays a pivotal role in overseeing production and laboratory assets across various sites that manufacture clinical and commercial drug products. This position requires a blend of technical expertise and maintenance coordination to ensure the reliability and compliance of equipment operations.
- Diagnose, troubleshoot, and rectify performance issues or equipment failures.
- Monitor and report on equipment downtime and failure patterns, implementing corrective measures to mitigate future occurrences.
- Coordinate maintenance, calibration, and certification activities with external service providers.
- Execute both preventative and corrective maintenance tasks effectively.
- Review and validate documentation provided by service providers.
- Manage task completion and documentation within the Computerized Maintenance Management System (CMMS).
- Ensure all production and laboratory equipment adheres to applicable Good Manufacturing Practices (GMP).
- Design and deliver training programs focused on asset operations and maintenance.
- Collaborate with colleagues to enhance equipment standards, practices, and procedures.
- Work alongside site MSAT and Engineering 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 required.
- A Bachelor's degree in Engineering or Life Sciences, with relevant experience in a GMP manufacturing setting.
- A minimum of 4 years' experience in a GMP facility, including hands-on experience with production equipment.
- Familiarity with reliability metrics and CMMS is preferred.
- 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.
- Proficient problem-solving and critical thinking abilities.
- Capability to work in clean room environments.
- Ability to function both independently and collaboratively within a team.
- Adaptability to a fast-paced startup culture while adhering to established procedures.
- Willingness to engage in process improvement initiatives.
- Comfortable working at a computer for extended periods.
- Occasional physical activity, including ascending/descending stairs and varying between sitting and standing/walking.
The anticipated annual salary range for this position is influenced by factors such as experience, education, and location. Remote candidates may see variations based on local market conditions. Additionally, employees are eligible for pre-IPO equity, comprehensive medical, dental, and vision benefits, flexible paid time off, a 401(k) plan, life insurance, and parental leave. Other perks include complimentary daily meals and snacks at our facilities.
Company CultureOrca Bio is driven by a passion for scientific advancement and a commitment to patient care. We uphold values of passion, courage, and integrity, recognizing the profound responsibility that comes with our work. Our entrepreneurial spirit fosters innovation and challenges conventional practices, all while maintaining a collaborative and inclusive workplace.
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