Engineer - Process

About the role

The Engineer – Process is responsible for establishing and maintaining the reliable operation and qualified state of the equipment and business processes in the area they support. They engage with cross-functional support teams as an equipment/automation subject matter expert to ensure the business meets defined safety, quality, and productivity goals.

Core Responsibilities

• Ensure a safe working environment by following safety rules and helping improve safety culture.
• Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvements.
• Responsible for the safe design and safe operation of the equipment within the area.
• Ensure that systems/solutions are in-control, compliant, and capable of meeting customer needs, while delivering projects associated with regulatory compliance, commercialization, capacity, and continuous improvement efforts.
• Demonstrate technical expertise of processes/equipment in area of responsibility, including clear understanding of equipment flow, process flow, critical process parameters, and standard operating procedures for the processes.
• Lead troubleshooting efforts to resolve difficult equipment and operational issues.
• Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve and communicate equipment issues.
• Engage with original equipment manufacturers and other service vendors to build knowledge base and deliver on projects and troubleshooting efforts.
• Communicate effectively with others, especially project team members, process team members, operations, maintenance, and crafts personnel.
• Perform impact assessments for varying levels of changes to responsible equipment/systems.
• Establish control systems and monitor/trend, as tools to verify and optimize equipment performance.
• Understand equipment reliability issues with the objective of process improvement.
• Identify and drive improvements associated with equipment within the area.

Basic Qualifications

• Bachelor’s degree in an engineering field, with preference to Mechanical or Electrical Engineering disciplines.
• 1+ years of engineering experience in a GMP or highly regulated environment.

Additional Skills/Preferences

• Experience in pharmaceutical manufacturing, parenteral, and/or packaging processes.
• Experience in Commissioning & Qualification, asset delivery, validation activities, and cGMP regulations.
• Demonstrated ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations.
• Experience utilizing and implementing various tools, systems, and processes resulting in improved operational excellence.

Additional Information

• 8-hour dayshift work schedule.
• Must be willing to work extended hours during peak periods.
• Must be willing to respond to off-hour support needs, as necessary.
• Occasional travel may be required for project delivery activities, training, conferences, capital projects, etc.