What are the responsibilities and job description for the Manufacturing Engineer position at Novozen Healthcare LLC?
Manufacturing Engineer
Position Summary
We are seeking a skilled Manufacturing Engineer with 4–6 years of experience in the pharmaceutical industry to support manufacturing operations, process improvements, equipment optimization, and compliance initiatives within a GMP-regulated environment. The ideal candidate will have hands-on experience supporting pharmaceutical production processes, troubleshooting manufacturing issues, and driving continuous improvement initiatives to enhance operational efficiency, product quality, and regulatory compliance.
Key Responsibilities
- Support daily pharmaceutical manufacturing operations to ensure safe, compliant, and efficient production activities
- Monitor and optimize manufacturing processes, equipment performance, and production workflows
- Lead process improvement initiatives focused on productivity, cycle time reduction, waste elimination, and operational efficiency
- Collaborate with Production, Quality, Validation, Maintenance, and Engineering teams to resolve manufacturing issues and implement corrective actions
- Support equipment qualification, commissioning, validation, and change control activities
- Conduct root cause investigations, deviation investigations, and CAPA implementation activities
- Develop, review, and revise SOPs, batch records, work instructions, and engineering documentation
- Support technology transfer, scale-up, and process validation activities for pharmaceutical products
- Ensure compliance with FDA, cGMP, OSHA, and internal quality standards
- Participate in risk assessments, FMEA activities, and continuous improvement programs
- Coordinate with vendors and contractors for equipment installation, maintenance, and project execution
- Analyze manufacturing data and generate reports to support operational and quality improvements
Required Qualifications
- Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Biomedical Engineering, or related discipline
- 4–6 years of manufacturing engineering experience within the pharmaceutical, biotech, or life sciences industry
- Strong knowledge of FDA regulations, cGMP requirements, and pharmaceutical manufacturing processes
- Experience supporting manufacturing equipment, utilities, and process systems in regulated environments
- Hands-on experience with deviation investigations, CAPA, root cause analysis, and change control processes
- Experience authoring and reviewing GMP documentation including SOPs, batch records, protocols, and technical reports
- Familiarity with validation and qualification activities including IQ/OQ/PQ
- Strong problem-solving, troubleshooting, and communication skills
- Ability to work effectively within cross-functional teams in a fast-paced manufacturing environment
Preferred Qualifications
- Experience with aseptic manufacturing, fill-finish, biologics, or oral solid dosage manufacturing
- Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies
- Experience with MES, SAP, Maximo, TrackWise, or other manufacturing systems
- Exposure to automation systems, PLCs, SCADA, or process control systems
- Prior experience supporting regulatory inspections and audit readiness activities