Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking a Junior Manufacturing Process Engineer to support manufacturing operations and process improvement in regulated pharmaceutical or life sciences environments. The role focuses on process optimization, qualification and validation, compliance, data analysis, troubleshooting, technology transfer, and technical documentation.
Responsibilities
- Assist in developing, optimizing, and improving manufacturing processes for drug products, including solid, liquid, and biologic products
- Support process qualification and validation activities, including IQ, OQ, and PQ
- Monitor manufacturing processes and identify opportunities for efficiency and performance improvement
- Ensure processes comply with Good Manufacturing Practices (GMP) and applicable FDA guidelines
- Collect and analyze process data and prepare technical reports
- Assist with troubleshooting process deviations and implementing CAPA (Corrective and Preventive Actions)
- Collaborate with Quality Assurance (QA), Quality Control (QC), and Production teams
- Support technology transfer activities from R&D to manufacturing
- Maintain technical and process documentation for audits and regulatory submissions
Skills
- Experience: 0–2 years
- Basic understanding of:
- Chemical Engineering principles, including mass transfer and thermodynamics
- Pharmaceutical, biotechnology, or manufacturing processes
- Knowledge of:
- Good Laboratory Practices (GLP)
- Good Documentation Practices (GDP)
- Familiarity with:
- Process equipment such as reactors, fermenters, filtration systems, and related manufacturing equipment
- Basic data analysis using Excel
- Knowledge of Minitab is preferred
Benefits
- Remote work
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