Principal Engineer, Automation Engineering (Controls System Hardware)

Quick Facts

• Role: Principal/Sr. Principal Engineer, Automation Engineering (Controls System Hardware)

• Focus: GMP process automation and control systems for manufacturing startup and ongoing operations

Description

You will provide automation engineering support for one or more operating areas and capital projects, with primary focus on instrumentation and control hardware. The role leads design, development, commissioning, qualification, tuning, and troubleshooting of process automation systems using DeltaV and Rockwell platforms. You will also mentor engineers and collaborate across process control and cross-functional teams to deliver reliable and compliant control applications.

Responsibilities

• Lead site operation support, capital project execution, and commissioning & qualification

• Translate technical concepts for executive audiences and non-technical stakeholders

• Perform automation engineering activities for Process Automation projects using DeltaV DCS (including control loop tuning and troubleshooting)

• Develop and implement the Automation Engineering Project Plan

• Define strategies for periodic and corrective maintenance of instruments and control hardware

• Resolve complex technical challenges involving instrument and control system hardware

• Develop and review Functional Requirements, Design Specifications, and Test Specifications

• Apply a thorough understanding of 21 CFR Part 11 and GMP processes

• Develop and utilize Master Maintenance Plans

• Lead/participate in design reviews and site system hardware reviews; attend equipment FATs

• Provide periodic status updates to Leadership and Project Management

• Implement and support electronic systems such as plant historians to capture production data

• Maintain the validated state of site control system hardware with validation strategies and documentation

• Promote automation to improve productivity, operational efficiency, and compliance

• Mentor the process control team and strengthen technical capabilities and best practices

• Participate in flow leadership and technical sub-teams during plant operations and startup

Requirements

• Minimum B.S. in Engineering or related degree

• Principal level: 5+ years experience in biopharma automation engineering

• Senior Principal level: 8+ years experience in biopharma automation engineering

• Experience with highly automated biopharmaceutical manufacturing using DeltaV DCS and Rockwell Allen-Bradley PLCs from design through startup

• Knowledge of GMP, regulatory requirements, and computer system validation

• Available for rotational on-call schedule

Benefits

• Eligibility to participate in a company-sponsored 401(k)

• Pension

• Vacation benefits

• Medical, dental, vision, and prescription drug benefits

• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)

• Life insurance and death benefits

• Time off and leave of absence benefits

• Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs and activities)

• Company bonus eligibility for full-time equivalent employees (based on company and individual performance)