Sr. Process Engineer

United Pharma; West Virginia; On-site; USD 120,000 - 150,000; Full time

Job summary

United Pharma seeks an experienced Senior Process Engineer to lead aseptic processing system design and commissioning. You will support dairy operations from receiving to packaging, ensuring safety, quality, and regulatory compliance.

Expect hands-on troubleshooting, CAPA support, and continuous improvement across processes and utilities. The role emphasizes cross-functional leadership, data-driven decision making, and adherence to FDA/USDA GMP standards within a fast-paced manufacturing

Qualifications

• Bachelor’s degree in Process, Chemical, or Mechanical Engineering.
• 5–7 years in aseptic processing or regulated manufacturing.
• Experience with low-acid aseptic processing, UHT, pasteurization, filling/packaging.
• Familiarity with FDA/USDA GMP ISO OSHA requirements.
• Strong troubleshooting and data analysis skills.

Responsibilities

• Lead design, installation, commissioning, maintenance, and improvement of aseptic equipment and plant systems.
• Provide process engineering support for dairy receiving, batching, blending, pasteurization, UHT, filling, and packaging.
• Troubleshoot issues using Fishbone Analysis and 8D methodologies.
• Support CAPA, investigations, and corrective actions for regulatory compliance.
• Improve equipment reliability, data collection, and obsolescence management.
• Develop SOPs, batch records, validation protocols, specs, and change control docs.
• Support process scale-up, implementation, and onsite troubleshooting.
• Monitor plant utility systems (RO water) and support facility performance.

Skills

Aseptic processing

Regulatory compliance

Problem solving (Fishbone/8D)

Data analysis

Cross-functional collaboration

Project leadership

Education

Bachelor's degree in Process, Chemical, or Mechanical Engineering

Tools

Allen-Bradley

Siemens

B&R

HMIs

Job description

We are seeking an experienced Senior Process Engineer to lead the design, installation, commissioning, and continuous improvement of low-acid aseptic processing systems and equipment. The role will provide engineering support across dairy receiving, batching and blending, pasteurization, UHT processing, aseptic filling, and packaging operations while ensuring safety, quality, regulatory compliance, and production efficiency.

Key Responsibilities:

• Lead the design, installation, commissioning, maintenance, and improvement of aseptic processing equipment and plant systems.
• Provide process and engineering support for dairy receiving, batching, blending, pasteurization, UHT processing, aseptic filling, and packaging.
• Troubleshoot manufacturing and equipment issues using structured problem-solving tools such as Fishbone Analysis and 8D.
• Support CAPA, process investigations, and corrective actions to meet FDA and USDA regulatory requirements.
• Improve equipment reliability, data collection, utilization, efficiency, and obsolescence management.
• Develop and review SOPs, batch records, validation protocols, equipment specifications, and change control documentation.
• Support process scale-up, implementation, and onsite troubleshooting activities.
• Monitor plant utility systems, including RO water systems, and support facility utility performance.

Required Skills & Qualifications:

• Bachelor's degree in Process, Chemical, or Mechanical Engineering.
• 5-7 years of engineering experience in aseptic processing or a regulated manufacturing environment.
• Experience with low-acid aseptic processing, UHT systems, pasteurization, and filling/packaging equipment.
• Knowledge of FDA, USDA, GMP, ISO, and OSHA requirements.
• Strong troubleshooting and problem-solving skills, including Fishbone Analysis and 8D methodologies.
• Ability to analyze process and equipment performance data and drive continuous improvement.
• Working knowledge of mechanical, process, and automation systems, including Allen-Bradley, Siemens, B&R, HMIs, and alarms.
• Strong communication, leadership, organizational, and cross-functional collaboration skills.