Equipment Engineer
The primary function of the Equipment Engineer is to maintain all production instruments in a fast paced DNA synthesis environment. The Equipment Engineer will test production instruments for daily, weekly, and monthly quality metrics, maintain documentation of such tests, troubleshoot, perform general, routine and preventative maintenance on all equipment and schedule service calls as needed. The ideal candidate would be self-motivated and perform other production duties as required.
What You’ll Be Doing
- Assume ownership of performing installation qualification, operational qualification, and performance qualification on new equipment and existing equipment
- Assume ownership of performing routine preventative maintenance and calibration of equipment in accordance with equipment manufacturer specifications
- Find proper and lasting fixes on recurring equipment failure by either reducing or eliminating the failures
- Utilize and improve the equipment risk assessment techniques so that prioritization can be given to all resources and how they are managed
- Owns and ensures timely closure of equipment related CAPAs and Change Controls
- Analyze equipment malfunctions and failures and accordingly develop corrective and preventive actions
- Develops effective Out of Control Action Plan (OCAP) procedures
- Recommend design changes or substitution of materials when appropriate.
- Maintain a high degree of expertise with the group by assisting in the training and development of New and Existing Equipment Engineers who are responsible for the repair, maintenance, and calibration of existing equipment
- Perform studies and design to determine critical inputs and outputs used to drive equipment improvement and reliability
- Perform detailed design for small to mid-scale projects, including drawing mark-ups, load calculations, coordination studies, voltage calculations, power requirements on equipment specifications, adherence to company standards and applicable codes.
- Investigates and implements countermeasures to prevent the repetitive breakdown of parts; maintains spare parts inventory to ensure appropriate level of available parts
- Must be able to adapt to assignments are broad in nature, requiring originality and ingenuity, and rely on collaboration, limited experience, and judgment to plan and accomplish goal
- Work closely with process engineers to understand equipment interactions and limitations relative to operating specifications
What You’ll Bring to the Team
- BS in Engineering or Sciences field or related technical discipline.
- Experience working under ISO 9001, GMP/cGMP or ISO 13485 Quality Management System is a plus
- Excellent interpersonal and teamwork skills.
- Excellent organizational skills and high attention to details
- Ability to multi-task in a dynamic environment with changing priorities
- Ability to design and build simple project to improve equipment performance and reliability using mechanical, electrical, electronics, electro-mechanical up to but not limited to PLC Programming and other control systems
- Able to make drawings for layout and equipment power load, and other utility requirements
- Experience with automated liquid handlers a plus.
- Minimum of 3 years of experience in equipment maintenance, calibration, and repair.
- Must be able to work in a clean room environment (lab covering, hairnets, gloves, etc).
