Senior Instrument Engineer

Role Summary

We are looking for an experienced Instrument Engineer to join our team. Our Instrument Engineers support projects for new and/or replacement instruments and ensure they are fit-for-purpose. In this role, you will support authoring and maintaining configuration specifications for manufacturing equipment for the production of our life-changing products.

Responsibilities

• Operating as a project manager; planning, executing, and closing projects within scope, time and budget constraints
• Specifying cGMP process instrumentation, components, and spare parts
• Setting priorities for and completing Calibration Range and Tolerance Justifications forms for new instruments
• Evaluating new instruments for Functional Equivalence to existing instrumentation that has become obsolete
• Reviewing and approving input/output lists for automated systems
• Conducting troubleshooting and root cause analysis for complex instrumentation and associated systems
• Creating and maintaining configuration specifications for cGMP manufacturing equipment
• Assisting in the design review of equipment, and approved supplier lists for instrumentation
• Writing and executing test plans to demonstrate instrument suitability
• Implementing corrective/preventative actions for existing equipment
• Preparing engineering evaluations and test plans for change control documentation
• Possibly supervising engineering contractors

Qualifications

• Required: Demonstrated ability to guide the prioritization, coordination, and completion of multiple projects within tight timeframes, while maintaining a high level of attention to detail
• Required: Understanding of common process instrumentation including but not limited to load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors
• Required: Excel at working independently as part of a broader multi-functional team
• Required: Ability to think independently to make quality decisions based on analyzing available and potentially limited information
• Required: Comfort working in an ambiguous environment with changing priorities
• Required: Experience utilizing advanced problem-solving methods and leadership for investigations
• Required: Familiar with equipment specification requirements
• Required: Outstanding written, verbal, and interpersonal communication skills with the ability to interact with team members with tact and diplomacy
• Required: Able to understand and implement project plans and schedules
• Preferred: Understanding of process control systems and automation
• Preferred: Direct experience with biopharmaceutical process equipment is highly desirable
• Experience levels: Senior Instrument Engineer: 5+ years; Principal Instrument Engineer: 8+ years (level determined by qualifications)

Education

• BS/BA in Engineering (Electrical Engineering preferred)
• 5+ years for Senior Instrument Engineer; 8+ years for Principal Instrument Engineer (as applicable)