Job Description

We are looking for an experienced Process Engineer to support pharmaceutical manufacturing processes, equipment, process optimization, technology transfer, and validation activities.

Responsibilities:

• Provide engineering support for pharmaceutical manufacturing and process operations.
• Support process development, optimization, scale-up, technology transfer, and process improvement activities.
• Troubleshoot process and equipment issues affecting quality, yield, throughput, and production performance.
• Develop and review process flow diagrams, P&IDs, process descriptions, equipment specifications, and technical documentation.
• Support equipment selection, installation, commissioning, startup, and qualification.
• Participate in process validation, PPQ, engineering runs, and manufacturing readiness activities.
• Support deviations, investigations, CAPA, change controls, and root cause analysis.
• Evaluate process performance and identify opportunities for improved efficiency, reliability, capacity, and cycle time.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, Automation, Engineering, and external vendors.
• Support technology transfer and implementation of new processes and equipment.
• Develop technical reports, SOPs, process documentation, and engineering deliverables.
• Ensure process engineering activities comply with cGMP, FDA requirements, and site procedures.

Qualifications:

• Bachelor's degree in Chemical, Mechanical, Biochemical, Pharmaceutical, or related Engineering discipline.
• 3+ years of pharmaceutical, biotechnology, or regulated manufacturing experience.
• Experience with pharmaceutical manufacturing processes and process equipment.
• Knowledge of process validation, PPQ, technology transfer, and GMP requirements.
• Strong troubleshooting, analytical, and problem-solving skills.
• Experience with PFDs, P&IDs, process equipment, and engineering documentation.
• Experience with upstream, downstream, formulation, fill-finish, or other pharmaceutical manufacturing processes is a plus.

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