Process & Controls Engineer (Automation Engineer)

Note from HM:

• Standard business hours with some opportunity for overtime

• Department is responsible for maintaining pharmaceutical packaging line equipment and improvement projects to the packaging line process

• will come in and support packaging line equipment in place

• We are not looking to fresh out of school, should have at least 3-5 years of experience but *seeking 5-10 years of experience*

• This needs to be a senior level leader, please ensure this is identified also in soft skills with your screening process

• PLC / HMI experience (Rockwell, Allen Bradley is highly preferred, Siemens is also okay)

• Vision system experience is helpful but can be trained as long as PLC experience is there

• Process and controls engineer experience

• Electrical engineering / computer engineering degree aligns well with this role

• GMP background is helpful (food / vet background is transferrable)

Position Overview:

We are looking for a Process & Controls Engineer (Automation Engineer) who will take ownership of the technical aspects of a manufacturing line under general supervision. The ideal candidate will bring expertise in process optimization, troubleshooting operational issues, and supporting packaging operations, manufacturing, pilot technologies, and capital projects. The role involves applying fundamental engineering principles to the design and execution of system modifications, experiments, and smaller-scale capital projects. As a key technical resource, the Process & Controls Engineer will collaborate closely with mechanics, automation technicians, and IS teams to solve complex engineering problems and drive process improvements.

Key Responsibilities:

• Technical Ownership: Lead and manage the technical aspects of automation systems for packaging and ancillary equipment, ensuring optimal functionality and performance.
• Process Optimization & Problem Solving: Analyze and develop strategies to optimize manufacturing processes, focusing on minimizing downtime and improving operational efficiency in a highly regulated environment.
• Leadership & Collaboration: Lead cross-functional teams and projects, driving continuous improvement and automation initiatives across departments including Research, Manufacturing, Process Development, Quality Assurance, and Validation.
• Engineering Design & Implementation: Contribute to the design, specification, and implementation of system modifications, experiments, and capital projects. Ensure effective deployment of new or improved engineering techniques and procedures.
• Cross-Functional Coordination: Work with various departments to define and develop requirements for complex system modifications and facility improvements.
• Documentation & Compliance: Ensure that all engineering processes, changes, and updates adhere to applicable industry standards (e.g., GMP, GAMP), maintaining compliance with relevant documentation and validation protocols.
• Validation & Lifecycle Management: Oversee the lifecycle of automation systems, including design, installation, validation, and ongoing performance monitoring.

Qualifications:

Basic Qualifications:

Master's degree in Engineering (preferred)

OR

Bachelor's degree in Engineering with at least 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries

OR

Associate’s degree in Engineering with 6 years of relevant experience in the Pharmaceutical, Medical Devices, or Biotechnology industries

Preferred Qualifications:

• Advanced degree in Mechatronics, Computer Engineering, Electrical Engineering, Mechanical Engineering, or Chemical Engineering
• Knowledge and experience with pharmaceutical/biotech processes, particularly in final drug product operations
• Familiarity with Data Integrity and Data Security in regulated environments
• In-depth experience with programming, design, installation, validation, and lifecycle management of manufacturing process controls and automation systems
• Experience with Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platforms
• Strong understanding of GMP (Good Manufacturing Practices) and GAMP (Good Automated Manufacturing Practice), including associated documentation requirements in regulated industries
• Experience with validation protocols and knowledge of the processes and requirements for new equipment installations
• Strong project management skills with proven ability to handle complex tasks and drive improvements
• Excellent verbal and written communication, presentation, and technical writing skills
• Proven ability to collaborate with cross-functional teams and lead projects from conception to completion
• Familiarity with Operational Excellence and Lean Transformation principles, particularly in automation and engineering contexts
• Expertise in PLC and HMI programming with specific experience in Rockwell, B&R, and Siemens systems

Why is the Position Open?

Planned Project

Top 3 Must Have Skill Sets:

Strong PLC and HMI Troubleshooting (Rockwell, B&R, Siemens)

Strong communication and teamwork skills

Root Cause Analysis and Troubleshooting

Day to Day Responsibilities:

Support the commercial operations of 7 packaging lines.

Lead small continuous improvement projects

Work with maintenance on breakdowns of packaging equipment.

Possible Extension:

Yes

Red Flags:

Validation Engineer

No engineering experience

No controls experience

Interview Process:

Virtual