Process Engineer

Position Title: Process Engineer – Device Management - Process Improvement and Acceleration Team

Position Type: Full-Time / Long-term Contract
-to-hire

Location: Indianapolis, IN

Position Overview:

Our top Pharmaceutical Manufacturing client, in collaboration with Brooksource Engineering Services, is seeking skilled Process Engineers for our Device Management operations. This role is critical in driving batch efficiencies, mechanical improvements, and optimizing processes related to packaging and device assembly. As a Process Engineer, you will be a key contributor to improving the efficiency, quality, and reliability of our manufacturing processes while collaborating closely with cross-functional teams.

You will focus on incorporating batch and mechanical efficiencies, working alongside project teams to ensure seamless equipment integration, optimization, and continuous improvement within the packaging and device assembly processes. This is a unique opportunity to impact high-quality production lines in a fast-paced, dynamic environment.

• Process Optimization and Efficiency - Lead efforts to improve batch and mechanical efficiencies within packaging and device assembly processes.
• Process Improvements - Identify and implement process improvements to reduce cycle times, increase output, and ensure the highest quality standards.
• Collaboration - Collaborate with production teams to resolve issues related to equipment, process variability, and system bottlenecks.
• Automation - Drive automation and integration initiatives to enhance the reliability and scalability of processes.

• Serve as the technical lead for equipment and process optimization initiatives, partnering with cross-functional teams, including Operations, Engineering, Maintenance, and Quality.
• Provide technical expertise in the installation, commissioning, and qualification of new packaging and assembly systems.
• Support commissioning and qualification (C&Q) activities, process validation, and ramp-up to full-scale production.
• Lead troubleshooting efforts and resolution of process and equipment-related issues, utilizing root cause analysis (RCA) and formal problem-solving methodologies.

• Ensure a safe working environment by adhering to and enforcing all Health, Safety, and Environmental (HSE) policies and guidelines.
• Participate in and lead safety audits, hazard assessments, and safety improvement activities.
• Promote a culture of safety by ensuring that proper personal protective equipment (PPE) is utilized and that safety standards are met or exceeded.

• Develop and maintain detailed process documentation, including standard operating procedures (SOPs), work instructions, and training materials.
• Train operators and maintenance personnel on new equipment, processes, and best practices to ensure consistent and safe operation.
• Ensure that all processes and equipment adhere to GMP, regulatory, and corporate quality standards.
• Monitor performance metrics and KPIs to track the effectiveness of process improvements.
• Analyze data to identify trends and opportunities for further optimization.
• Lead continuous improvement initiatives by applying Lean Six Sigma, Kaizen, or other methodologies to increase process efficiency.

• Experience in Packaging or Device Start-Up:
  Demonstrated success in supporting start-up or ramp-up activities for packaging lines or device assembly in a regulated manufacturing environment.
• Commissioning & Qualification (C&Q):
  Experience in C&Q processes for packaging equipment and device lines, with a thorough understanding of operational readiness, testing protocols, and documentation.
• Validation and Regulatory Compliance:
  Hands-on experience in process validation and a solid understanding of GMP and regulatory requirements for pharmaceutical packaging processes.
• Analytical and Problem-Solving
  
  Skills:
  
  Proven ability to identify root causes of packaging process issues and implement effective corrective actions and continuous improvements.

• Bachelor’s Degree in Engineering (Mechanical, Packaging, Chemical, or related field).
• Certification in packaging engineering or related disciplines.
• Knowledge of Pharmaceutical Device Operations and familiarity with equipment such as labelers, sealers, automated packaging systems, or auto injectors.
• Strong Communication and Documentation
  
  Skills:
  
  Able to clearly communicate technical information, collaborate effectively across departments, and maintain accurate project documentation.

• Mid-Senior level

• Contract

• Pharmaceutical Manufacturing and Engineering Services