Process Engineer III

Role Summary

We are seeking a hands-on Process Engineer III to support a life sciences manufacturing environment focused on chemical manufacturing processes. This role will support technology transfer, equipment and process validation, process optimization, scale-up, and manufacturing support.

Responsibilities

• Lead equipment installation and qualification activities, including IQ/OQ/PQ.
• Lead process validation and support technology transfer of chemical manufacturing processes.
• Develop process flow diagrams, mass and energy balances, and technical documentation.
• Perform FMEA, HAZOP, and quality/safety risk assessments.
• Develop and execute work instructions and manufacturing procedures.
• Provide technical support for process deviations, investigations, and corrective actions.
• Drive process improvements using data, statistical tools, and process control methods.
• Support GMP/cGMP, ISO, change control, and quality requirements.
• Work closely with Manufacturing, Quality, Engineering, and other cross-functional teams.

Required Qualifications

• Bachelor's degree or higher in Chemical Engineering or a related field.
• 7–10 years of relevant engineering experience, preferably in chemical manufacturing.
• Hands-on experience with chemical process technology transfers.
• Strong experience with equipment/process validation (IQ/OQ/PQ).
• Experience with FMEA, HAZOP, deviation investigations, and change control.
• Knowledge of GMP/cGMP and ISO standards.
• Experience with large-scale process optimization and scale-up.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Lean Manufacturing, Six Sigma, statistical process control, and statistical analysis experience.

Candidate Focus

We are prioritizing hands-on Process Engineers with strong chemical manufacturing and validation experience. Please avoid Manager-level or significantly overqualified candidates. Candidates previously submitted or interviewed with the client should not be resubmitted.