Work Location: Middlesex County, Massachusetts

Summary:

Seeking a process engineer to join a collaborative team focused on tech transfer, validation, and optimization of chemical manufacturing processes. This role requires strong leadership, technical, and operational skills to support process improvements and ensure safety and quality standards.

Responsibilities:

• Lead installation and qualification of process equipment, including process validations (IQ/OQ/PQ).
• Develop and execute work instructions for new and existing chemical processes.
• Generate process flow diagrams, mass and energy balances, and conduct safety and quality risk assessments.
• Investigate process deviations and implement corrective actions to maintain operational integrity.
• Drive continuous process improvements using data-driven decision making.
• Promote a culture of safety and quality throughout all operations.
• Collaborate with cross-functional teams on the production floor and in other departments.
• Travel as required to support process engineering activities and project needs.

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 ISO standards and cGMP.
• Experience with risk assessments (HAZOP, FMEA), deviation investigations, and change control.
• Understanding of 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.
• Demonstrated safety-first mindset and commitment to quality culture.

Published Category: Manufacturing & Technical Operations