United Consulting HubRemote
Junior Manufacturing Engineer
United States of America
Contract
1 week ago
H1B Sponsor Likely
Key skills
Pharmaceutical manufacturing processesUnit operationsManufacturing Practices (GMP)U.S. Food and Drug Administration (FDA) regulationsBatch Manufacturing Records (BMR)Standard Operating Procedures (SOP)Change control processesEquipment qualification (IQ/OQ/PQ)Process validationLeanSix SigmaCommunication
About this role
United Consulting Hub is seeking a motivated and detail-oriented Junior Manufacturing Engineer to support pharmaceutical and life sciences manufacturing operations. This role is ideal for recent graduates with a background in engineering who are eager to build a career in regulated environments.
Responsibilities:
- Support manufacturing operations for API and formulation processes
- Assist in scale-up from lab to commercial production
- Troubleshoot process deviations and production issues
- Improve yield, efficiency, and cycle time
- Perform root cause analysis for process failures
- Implement continuous improvement initiatives (Lean/Six Sigma basics)
- Ensure compliance with Good Manufacturing Practices (GMP)
- Follow regulations set by the U.S. Food and Drug Administration (FDA)
- Prepare and review Batch Manufacturing Records (BMR)
- Develop and maintain SOPs and manage change control processes
- Support equipment qualification (IQ/OQ/PQ)
- Assist in process validation and audits with QA/QC teams
Requirements:
- 0–2 years of experience
- Motivated and detail-oriented
- Background in Chemical, Pharmaceutical, Biomedical, Biotechnology, or Mechanical Engineering
- Support manufacturing operations for API and formulation processes
- Assist in scale-up from lab to commercial production
- Troubleshoot process deviations and production issues
- Improve yield, efficiency, and cycle time
- Perform root cause analysis for process failures
- Implement continuous improvement initiatives (Lean/Six Sigma basics)
- Ensure compliance with Good Manufacturing Practices (GMP)
- Follow regulations set by the U.S. Food and Drug Administration (FDA)
- Prepare and review Batch Manufacturing Records (BMR)
- Develop and maintain SOPs and manage change control processes
- Support equipment qualification (IQ/OQ/PQ)
- Assist in process validation and audits with QA/QC teams
- Basic understanding of pharmaceutical manufacturing processes
- Knowledge of unit operations (mixing, granulation, filtration, etc.)
- Familiarity with GMP and regulatory compliance
- Strong problem-solving and analytical thinking
- Good communication skills (collaborating with QA, QC, and production teams)
- Internship or academic project experience in pharma manufacturing
- Exposure to validation, quality systems, or regulatory practices