Manufacturing Engineer

United Pharma; California; Presencial; USD 120.000 - 180.000; Tempo integral

Resumo da vaga

United Pharma is seeking an experienced API Manufacturing Engineer to support GMP-regulated API production operations in California. The role emphasizes process engineering, troubleshooting, and continuous improvement across manufacturing, quality, and maintenance teams.

The ideal candidate brings 5+ years in chemical/pharmaceutical manufacturing, hands-on equipment experience, and a strong commitment to product quality and safety. Join a fast-paced, compliant environment focused on efficiency.

Qualificações

• Bachelor's degree in Chemical Engineering or related technical discipline.
• 5+ years of API or chemical manufacturing experience.
• Hands-on GMP-regulated pharmaceutical manufacturing experience.

Responsabilidades

• Provide technical and engineering support for day-to-day API manufacturing operations.
• Monitor and optimize processes to improve productivity and quality.
• Troubleshoot process and equipment issues with reactors, centrifuges, dryers, and mills.
• Support scale-up, startup, changeovers, and improvements.
• Develop and update batch records, SOPs, and GMP documentation.
• Lead or support root cause investigations, deviations, CAPAs, and corrective actions.
• Assist with equipment qualification, commissioning, and process validation.
• Collaborate with Manufacturing, Quality, Maintenance, and Engineering teams.
• Support process safety assessments and continuous improvement.
• Ensure activities comply with GMP, EH&S requirements.

Conhecimentos

API manufacturing

Process engineering

GMP compliance

Troubleshooting

Cross-functional collab

Formação

Bachelor's degree in Chemical Engineering

Ferramentas

Reactors

Centrifuges

Dryers

Mills

Descrição da vaga

We are seeking an experienced API Manufacturing Engineer to support Active Pharmaceutical Ingredient (API) production operations in a GMP-regulated manufacturing environment. The ideal candidate will have a strong background in chemical or pharmaceutical manufacturing, with hands-on experience in process engineering, production troubleshooting, equipment operations, and process optimization. This position will focus on improving manufacturing efficiency, ensuring product quality, supporting equipment readiness, and maintaining compliance with GMP and safety requirements.

Key Responsibilities

• Provide technical and engineering support for day-to-day API manufacturing operations.
• Monitor and optimize manufacturing processes to improve productivity, quality, and operational efficiency.
• Troubleshoot process and equipment issues involving reactors, centrifuges, dryers, mills, and other manufacturing equipment.
• Support process scale-up, equipment startup, product changeovers, and manufacturing improvements.
• Develop, review, and update batch manufacturing records, SOPs, work instructions, and GMP documentation.
• Lead or support root cause investigations, deviations, CAPAs, and corrective actions.
• Assist with equipment qualification, commissioning, and process validation activities.
• Collaborate with Manufacturing, Quality, Maintenance, and Engineering teams to resolve production challenges.
• Support process safety assessments, risk evaluations, and continuous improvement initiatives.
• Ensure manufacturing activities comply with GMP, environmental, health, and safety requirements.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline.
• 5+ years of experience in API manufacturing, chemical manufacturing, or process engineering.
• Hands-on experience in GMP-regulated pharmaceutical manufacturing operations.
• Strong knowledge of API manufacturing processes, process troubleshooting, and optimization.
• Experience with manufacturing equipment such as reactors, centrifuges, dryers, and mills.
• Understanding of process scale-up, equipment startup, and manufacturing documentation.
• Experience with batch records, SOPs, technical reports, and GMP documentation.
• Strong problem-solving, communication, and cross-functional collaboration skills.