The Equipment Engineer is responsible for ensuring the reliability and performance of all production instrumentation within a high-throughput DNA synthesis environment. You will be the primary lead for validating equipment, performing routine and preventative maintenance, and executing complex troubleshooting to minimize downtime.The ideal candidate is a self-motivated problem-solver who thrives in a fast-paced setting and is committed to maintaining the rigorous quality metrics required for cutting-edge biotechnology production.
Onsite Position - 5 Days per week in Wilsonville, Oregon.
What You’ll Be Doing
- Equipment Validation: Lead the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both new and existing instrumentation.
- Preventative Maintenance: Manage the scheduling and execution of routine maintenance and calibrations in strict accordance with manufacturer specifications and internal quality standards.
- Root Cause Analysis: Investigate recurring equipment failures to implement permanent engineering fixes, significantly reducing or eliminating downtime.
- Risk Management: Utilize and refine equipment risk assessment techniques to prioritize resources and optimize maintenance workflows.
- Quality Compliance: Own and ensure the timely closure of equipment-related CAPAs (Corrective and Preventive Actions) and Change Controls.
- Operational Control: Develop and implement effective Out of Control Action Plans (OCAP) and standard operating procedures.
- Continuous Improvement: Recommend design modifications or material substitutions to enhance equipment longevity; perform load calculations, voltage studies, and power requirement specifications for small-to-mid-scale projects.
- Training & Mentorship: Serve as a technical subject matter expert, assisting in the training and development of junior Equipment Engineers.
- Inventory & Logistics: Manage spare parts inventory to ensure immediate availability for critical repairs and implement countermeasures for repetitive part breakdowns.
- Cross-Functional Collaboration: Partner closely with Process Engineers to understand equipment-process interactions and ensure hardware operates within peak specifications.
What You’ll Bring to the Team
- Education: BS in Engineering, Physical Sciences, or a related technical discipline.
- Experience: Minimum of 3+ years of professional experience in equipment maintenance, calibration, and repair.
- Technical Versatility: Proven ability to design and build projects to improve reliability using mechanical, electrical, and electro-mechanical systems, including PLC programming and control systems.
- Design Skills: Proficiency in creating layouts, power load drawings, and utility requirement specifications.
- Quality Mindset: High attention to detail and strong organizational skills; experience working under ISO 9001, ISO 13485, or GMP/cGMP standards is highly preferred.
- Adaptability: Ability to multi-task in a dynamic environment and work comfortably in a cleanroom setting (requiring lab coats, hairnets, and gloves).
- Communication: Excellent interpersonal skills with a collaborative approach to problem-solving.
- Bonus Assets: Experience with automated liquid handlers or LIMS integration is a significant plus.
