Process Improvement Engineer

Job Responsibilities:

• Support continuous improvement and capital projects to enhance equipment reliability, process robustness, and overall manufacturing efficiency within a GMP-regulated environment.

• Provide engineering support for pharmaceutical production systems, including troubleshooting, process optimization, scrap and deviation reduction, and equipment capacity improvements.

• Lead cross-functional project teams to implement lean manufacturing initiatives that drive productivity, improve product quality, strengthen process control, and ensure regulatory compliance.

• Identify, prioritize, and execute improvement projects based on risk assessment, process impact, and alignment with operational and quality objectives.

• Conduct root cause investigations in support of CAPA (Corrective and Preventive Action) processes; document findings, propose and implement corrective measures, and verify long-term effectiveness.

• Author, review, and maintain SOPs related to equipment operation, cleaning, setup/changeover, and preventive maintenance to ensure accuracy and compliance with current GMP standards.

• Collaborate with vendors and internal stakeholders to define system specifications, obtain quotations, and support equipment procurement and qualification activities.

• Develop and manage project timelines, ensuring alignment with production schedules and quality requirements.

• Write, review, and execute validation documentation, including PVPs, IQ, OQ, PQ, as well as risk-based assessments such as FMEA and Risk Analyses (RA).

• Maintain a thorough understanding of cGMP, ISO 13485, and applicable FDA/EMA regulations governing pharmaceutical manufacturing and equipment validation.

• Support routine operations by diagnosing and resolving equipment or process deviations in collaboration with Maintenance, Quality, and Manufacturing teams.

Qualifications:

• Bachelor’s degree (or equivalent) in Biomedical, Mechanical, Chemical, or Manufacturing Engineering or related technical fields

• 3+ years of experience in a pharmaceutical, biopharmaceutical, or regulated manufacturing environment.

• Hands-on experience with IQ/OQ/PQ, FMEA, risk assessments, and validation documentation preferred.

• Strong understanding of cGMP, equipment qualification, and process validation principles.