Sr Engineer II

About This Role

The Sr. Engineer II, Instrumentation and Controls provides engineering technical support and troubleshooting for Manufacturing Process / Utilitiy Equipment and Laboratory Analytical instrumentation. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance, and others to measure, target and improve reliability of all assets. Supports design, specification, installation, commissioning, and qualification of new equipment including URS and protocol writing and executions. Support technical development of I&C Maintenance Technicians and junior engineers. The role requires the knowledge / use of multiple control systems (Centralized Building Management System, PLC, DeltaV) for troubleshooting and improvement.

What You'll Do

• Troubleshoot site operation issues and identify system improvements.
• Update standards, drawings, and specifications.
• Develop validation protocols and provide expertise in equipment and automation design/modifications.
• Author deviations, CAPA’s, and change control records in a GMP environment.
• Configure Instrumentation & Control (I&C) systems, including utilities, process and laboratory instrumentation, control system hardware, and software.
• Support capital and operational expenditure projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
• Source and supervise I&C contractors.
• Oversee lifecycle management for I&C systems and equipment, implement upgrades and continuous improvements.
• Provide interim supervision and training of I&C technicians.
• Represent the department in cross-functional/global teams to address issues, implement change, and improve processes.
• Maintain personal training, goal development/completion, investigations, compliance workflow activities, and progress tracking.
• Provide engineering and validation support for utility systems.
• Collaborate with other groups as a representative of the facilities engineering team.
• Complete work tasks with oversight from the Facilities Engineering manager.
• Coach and mentor junior Facilities Engineering staff.
• Contribute to the completion of milestones associated with specific equipment projects or deliverables.

Who You Are

You are a proactive problem-solver with a strong background in Instrumentation & Control systems. You are adept at troubleshooting, eager to improve existing systems, and capable of developing and updating technical documentation. You enjoy leading and collaborating with cross-functional teams, manage contractors, and mentor junior staff. You are an expert in Critical Risk Analysis and have a track record of successful project delivery.

Requirements

• BS in Electrical, Chemical, Mechanical or related engineering field.
• 7 years transferrable experience.
• Practical knowledge of the application of FDA GMP and EMA regulations.
• Prior experience with variety of control systems & HMI’s and the ability to program/configure these systems.
• Ability to read and understand electrical drawings and instrumentation datasheets/schematics.
• Experience with enterprise/IT systems.
• Demonstrates excellent oral and written communication skills.
• Competency in Microsoft Office Suite.
• May be asked to work extended shifts or weekends.