Job Title: Process Engineer

Work Location: Middlesex County, Massachusetts

Summary:

Seeking a Process Engineer to support chemical manufacturing process tech transfer, equipment validation, process optimization, and scale-up. The role requires strong technical, operational, and leadership skills, with a focus on safety, quality, and continuous improvement in a collaborative environment.

Responsibilities:

• Lead installation and qualification of process equipment, including process validations (IQ/OQ/PQ).
• Develop and execute work instructions for new and existing processes.
• Generate process flow diagrams, mass and energy balances, and conduct safety (HAZOP) and quality risk assessments (FMEA).
• Provide technical support for process deviations, including investigations and implementation of corrective actions.
• Drive process improvements using data-driven decision making and statistical tools.
• Promote a culture of safety and quality throughout the organization.
• Collaborate with cross-functional teams to support operational excellence and process optimization.
• Travel as required to support process engineering activities across different locations.

Qualifications:

• Bachelor's degree or higher in Chemical Engineering or a related field.
• 7-10 years of experience in a related field, with a focus on chemical manufacturing.
• Strong knowledge of process and equipment validation, including IQ/OQ/PQ.
• Understanding of ISO standards, risk assessments, deviation investigations, and change control.
• Familiarity with Good Manufacturing Practices (cGMP).
• Experience with statistical tools and statistical process control.
• Lean manufacturing and Six Sigma knowledge are advantageous.
• Excellent communication skills and ability to work effectively with cross-functional teams.
• Safety-first mindset and commitment to promoting a safe work environment.

Published Category: Manufacturing & Technical Operations