Process Engineer

Process Engineer

This Process Engineer role focuses on supporting capital projects and day-to-day manufacturing operations in a highly regulated, cutting-edge environment. You will improve production line performance, enhance equipment uptime, and drive continuous improvement across processes, equipment, and systems. The position offers the opportunity to work on both hands-on troubleshooting and larger-scale process design and equipment upgrade projects while collaborating closely with cross-functional teams.

Responsibilities

• Support capital projects involving manufacturing equipment, hardware, and control systems/software from concept through implementation.
• Maintain and improve production line performance by increasing equipment uptime, throughput, and overall operational efficiency.
• Troubleshoot equipment downtime, identify root causes, and implement sustainable corrective and preventive solutions.
• Partner with Safety and Quality teams to resolve compliance issues and process challenges in a highly regulated environment.
• Lead and support continuous improvement initiatives across manufacturing operations using structured methodologies.
• Develop and implement new manufacturing processes and optimize existing processes for consistency, efficiency, and quality.
• Ensure reliability, scalability, and robustness of processes to support new product introductions and technology transfers.
• Manage projects related to process design improvements and equipment upgrades, including planning, execution, and follow-up.
• Document findings, procedures, process changes, and technical work in a clear and compliant manner.
• Collaborate cross-functionally with R&D, Production, Quality, Maintenance, and external vendors to align on technical solutions and project goals.
• Present technical recommendations, prepare supporting data, and build business cases for process and equipment improvements.
• Contribute to maintaining a strong culture of safety, quality, and continuous improvement within manufacturing operations.

Essential Skills

• Bachelor's degree in Engineering (required).
• 5–8 years of Process Engineering experience.
• Experience working in pharmaceutical, chemical, or other highly regulated cGMP environments.
• Proven ability to troubleshoot manufacturing equipment and improve performance and reliability.
• Hands-on experience with manufacturing processes and process improvement in regulated industries.
• Knowledge of quality standards and compliance requirements in highly regulated manufacturing environments.
• Understanding of OSHA 1910 and hazardous environment safety practices.
• Experience supporting capital projects and managing elements of capital management.
• Strong project management skills, including planning, coordination, and execution of process and equipment initiatives.
• Background in process improvement and continuous improvement methodologies, including lean manufacturing principles.
• Strong communication and presentation skills, with the ability to explain technical concepts to diverse stakeholders.
• Comfort working both hands-on in production areas and on larger-scale engineering and capital projects.

Additional Skills & Qualifications

• Experience with pharmaceutical solutions, solvents, or similar products in a regulated environment.
• Background in biopharmaceutical, chemical manufacturing, refinery, or materials science environments.
• Familiarity with manufacturing processes and quality standards specific to highly regulated industries.
• Exposure to capital management practices and project justification through business cases.
• Knowledge of root cause failure analysis and reliability-centered approaches (e.g., RCFE).
• Experience applying lean manufacturing and continuous improvement tools to enhance process efficiency.
• Ability to collaborate effectively with R&D, Production, Quality, Maintenance, and external vendors.
• Strong analytical and problem-solving skills with a focus on data-driven decision-making.

Work Environment

The role typically operates in an office environment with adequate lighting, ventilation, and a normal range of temperature and noise level. You will also engage with manufacturing areas and equipment as needed to support process…