Process Engineer

Process Engineer

Position Overview

Our client is seeking a hands-on Process Engineer to support manufacturing operations within a highly regulated production environment. This role is ideal for an engineer with experience in pharmaceutical, chemical, or cGMP-regulated manufacturing who can balance daily production support with larger capital improvement and process optimization projects.

The Process Engineer will be responsible for improving production line performance, equipment uptime, product quality, operational efficiency, and overall process reliability. This individual will work closely with Manufacturing, Engineering, Maintenance, Safety, Quality, Procurement, and external vendors to troubleshoot process issues, support capital projects, and drive continuous improvement initiatives.

This is a 12-month contract assignment with potential for conversion to a permanent role.

Key Responsibilities

• Support day-to-day manufacturing operations in a regulated cGMP, pharmaceutical, chemical, or high-purity manufacturing environment.
• Troubleshoot production equipment downtime, process inefficiencies, and manufacturing variances.
• Analyze process data, identify trends, perform root cause analysis, and implement corrective and preventive actions.
• Partner with Safety, Quality, Maintenance, Engineering, R&T, and Production teams to resolve manufacturing, compliance, and process-related issues.
• Lead or support process capability improvements, validation efforts, change management activities, and continuous improvement projects.
• Support capital projects involving manufacturing equipment, control systems, automation, and process improvements.
• Develop business cases, technical recommendations, and project justifications for internal stakeholders.
• Work with Procurement, Production Leadership, and external vendors to implement improvement plans and support equipment/process upgrades.
• Track process reliability, equipment performance, product quality trends, throughput, yield, waste reduction, and production variances.
• Develop and maintain process metrics to reduce variability, improve equipment uptime, and enhance product quality.
• Support non-conforming product investigations, corrective action reports, complaint responses, and process improvement initiatives.
• Collaborate with plant engineering, R&T, and customers to support new products and new manufacturing technology platforms.
• Direct contractors and hourly employees during process monitoring, data collection, equipment installation, and process modifications.
• Maintain accurate documentation in accordance with quality, safety, environmental, and regulatory requirements.

Required Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 5 years of related process engineering experience.
• Minimum of 2 years of experience in chemical manufacturing or a similar regulated manufacturing environment.
• Experience working in pharmaceutical, chemical, cGMP, high-purity, or similarly regulated manufacturing environments.
• Strong preference for candidates with experience manufacturing pharmaceutical solutions, solvents, high-purity chemicals, or related products.
• Experience supporting both manufacturing equipment and control systems/software projects.
• Knowledge of basic problem-solving tools such as DMAIC.
• Working knowledge of Lean manufacturing concepts such as Kaizen, 5S, and Kanban.
• Strong communication, presentation, and technical documentation skills.
• Ability to work hands-on in a manufacturing environment while supporting larger capital and process improvement projects.

Preferred Qualifications

• Six Sigma Black Belt certification.
• Lean certification.
• Knowledge of OSHA, NFPA, HazWoper, cGMP, FDA, ISO, and other applicable regulatory requirements.
• Experience with 21 CFR Part 820, ISO 9000, FDA-regulated manufacturing, or similar quality systems.
• Experience with SPC tools and statistical process control.
• Experience with distillation, separation, purification technologies, chemical synthesis unit operations, process controls, environmental control systems, or clean manufacturing.
• Working knowledge of financial/cost systems, standard operating procedures, and business improvement planning.

Skills & Competencies

• Strong knowledge of chemistry, high-purity chemical processing, and process engineering principles.
• Strong analytical, troubleshooting, and complex problem-solving skills.
• Ability to understand analytical procedures, interpret results, and recommend process adjustments.
• Strong organizational skills with the ability to prioritize multiple projects and operational needs.
• Demonstrated technical leadership and ability to influence cross-functional teams.
• Strong sense of urgency, initiative, and ownership.
• Ability to partner effectively with all levels of the organization, including management, hourly employees, vendors, and technical teams.
• Strong Microsoft Office skills, including Excel, PowerPoint, and Word.

Work Environment & Schedule

• Contract length: 12 months, with potential for conversion.
• Schedule: Monday–Friday, standard business hours.
• Occasional early start times and overtime may be required based on production needs.
• Work will be performed in a regulated manufacturing environment.

Compensation

• Target pay rate: approximately $53.00 per hour.