Process Engineer – MSAT

United Pharma; New Jersey; On-site; USD 90,000 - 125,000; Full time

Job summary

United Pharma seeks a Process Engineer – MSAT to evaluate, develop, and scale up manufacturing processes for APIs. You will support technology transfer, manage process validation, and lead NPI activities to deliver compliant, high‑quality products.

You will coordinate with cross‑functional teams and external customers, applying strong analytical and problem‑solving skills to optimize yield, cost, and reliability in a fast‑paced manufacturing environment.

Qualifications

• Bachelor’s degree in Chemical Engineering or related field.
• 3+ years of manufacturing or process engineering experience in pharmaceutical, specialty chemical, or batch processing environments.
• Strong understanding of chemical manufacturing operations and process engineering principles.
• Experience with technology transfer, process scale-up, validation, and process improvement.
• Knowledge of FDA/cGMP requirements and regulated manufacturing practices.
• Strong statistical analysis, FMEA, and root cause analysis skills.
• Excellent troubleshooting, decision‑making, and problem‑solving abilities.
• Ability to work independently in a fast‑paced manufacturing environment.
• Strong communication and collaboration skills with both internal teams and external clients.

Responsibilities

• Evaluate, design, and implement new or improved processes transferred from development into manufacturing.
• Provide ongoing manufacturing and production support, including process monitoring and troubleshooting.
• Support technology transfer activities for processes moving into or out of manufacturing sites.
• Lead New Product Introduction (NPI) and process implementation activities.
• Monitor manufacturing operations to ensure safety, quality, yield, and efficiency objectives are achieved.
• Lead process improvement initiatives focused on yield improvement, cost reduction, and operational efficiency.
• Support scale‑up, process validation, and cleaning validation activities.
• Lead root cause analysis and troubleshooting of process and equipment issues.
• Develop and review batch records, validation protocols, process safety information, training materials, and technical reports.
• Analyze process performance data and identify opportunities for optimization and continuous improvement.

Skills

Statistical analysis

FMEA

Root cause analysis

Troubleshooting

Communication

Collaboration

Education

Bachelor’s degree in Chemical Engineering or related field

Job description

We are seeking a Process Engineer – MSAT to support the evaluation, development, scale-up, technology transfer, and optimization of manufacturing processes. This role will provide hands‑on production support while working with cross‑functional teams and external customers to ensure safe, efficient, compliant, and commercially viable processes that consistently deliver high‑quality API products.

Key Responsibilities:

• Evaluate, design, and implement new or improved processes transferred from development into manufacturing.
• Provide ongoing manufacturing and production support, including process monitoring and troubleshooting.
• Support technology transfer activities for processes moving into or out of manufacturing sites.
• Lead New Product Introduction (NPI) and process implementation activities.
• Monitor manufacturing operations to ensure safety, quality, yield, and efficiency objectives are achieved.
• Lead process improvement initiatives focused on yield improvement, cost reduction, and operational efficiency.
• Support scale‑up, process validation, and cleaning validation activities.
• Lead root cause analysis and troubleshooting of process and equipment issues.
• Develop and review batch records, validation protocols, process safety information, training materials, and technical reports.
• Analyze process performance data and identify opportunities for optimization and continuous improvement.

Required Qualifications:

• Bachelor’s degree in Chemical Engineering or a related technical discipline.
• 3+ years of manufacturing or process engineering experience in pharmaceutical, specialty chemical, or batch processing environments.
• Strong understanding of chemical manufacturing operations and process engineering principles.
• Experience with technology transfer, process scale‑up, validation, and process improvement.
• Knowledge of FDA/cGMP requirements and regulated manufacturing practices.
• Strong statistical analysis, FMEA, and root cause analysis skills.
• Excellent troubleshooting, decision‑making, and problem‑solving abilities.
• Ability to work independently in a fast‑paced manufacturing environment.
• Strong communication and collaboration skills with both internal teams and external clients.