Process Engineer (Building 3)

Summary:

The Building 3 Process Engineer will be responsible for analyzing, designing, and optimizing production processes to improve efficiency, quality, and safety. This role will work closely with cross-functional teams, including production, quality assurance, and maintenance to drive continuous improvement in a cGMP environment and support the plant’s operational goals.

Accountable Functions and Responsibilities:

Customer Focused:

• Understand customer requirements with regard to process and specification and assure both are integrated into operations.
• Provide exceptional process information and details to satisfy customer information requirements and requests.

CPS Focused:

• Collaborate with EHS, Quality, Maintenance, Logistics, Planning, and Technical Sales Engineering and Project Engineering to deliver the manufacturing plan within Job Metrics.
• Work with the Building 3 Plant Manager and operations team to deliver the revenue expected and committed to on a monthly basis

Key Functional Roles:

• Ensure all processes comply with safety, environmental, and regulatory standards.
• Ensure Building 3 operations are cGMP compliant at all times
• Prepare new Job Jackets (batch records) for commercial products and maintain templates for existing commercial products
• Develop and implement new or modified production processes, equipment, and workflows.
• Identify continuous improvement opportunities in productivity, cost reduction, and quality through analysis of existing manufacturing processes.
• Collaborate with maintenance and production teams to troubleshoot process-related issues.
• Lead or participate in root cause analysis and corrective actions for process deviations, customer complaints, or product quality concerns.
• Monitor key process parameters, track performance metrics, and generate regular reports for plant leadership.
• Support the commissioning, qualification, and validation of new equipment and processes.
• Support Plant Manager in maintaining accuracy of production elements of management information systems including financial reporting and ERP systems.
• Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Work with suppliers and vendors as needed to support equipment or process changes.

People Focused:

• Provide technical training and support to production personnel and help develop new training tools for use in the business unit.
• Provide a culture of engagement for all employees within the business unit.

Other Key Roles:

• Act as deputy to the Building 3 Plant Manager during vacation periods or other absences
• Share knowledge and expertise with Process Engineers in other business unit and Technical Sales Engineers to improve teamwork and collaboration
• Perform any other related duty as identified by Senior Leadership