Engineering Manager

Job Summary:

We are seeking a highly skilled and motivated Pharmaceutical Engineer to join our team. The ideal candidate will be responsible for developing, optimizing, and maintaining the systems and processes used in the manufacturing of pharmaceutical products. You will collaborate with cross-functional teams to ensure adherence to industry standards, regulatory requirements, and company goals. Your work will directly impact the quality, efficiency, and safety of pharmaceutical production.

Key Responsibilities:

• Process Design & Optimization: Develop, evaluate, and optimize pharmaceutical manufacturing processes to ensure efficiency, scalability, and product quality.
• Equipment Selection & Maintenance: Identify and recommend appropriate equipment for manufacturing processes; oversee equipment installation, calibration, and maintenance to ensure optimal performance.
• Compliance & Regulations: Ensure that all processes comply with regulatory requirements, including FDA, GMP (Good Manufacturing Practice), and other industry standards.
• Troubleshooting & Problem-Solving: Identify and resolve technical issues related to equipment, systems, or processes in the production line.
• Process Validation: Conduct process validation and qualification activities to ensure that manufacturing processes meet predefined criteria and standards.
• Continuous Improvement: Implement continuous improvement initiatives (such as Lean, Six Sigma) to reduce waste, enhance efficiency, and maintain product quality.
• Collaboration: Work closely with production, quality control, and R&D teams to implement new technologies or processes.
• Documentation & Reporting: Maintain accurate documentation for all processes, equipment, and validation activities, and prepare detailed reports for regulatory compliance and audits.
• Safety & Risk Management: Ensure a safe working environment by identifying risks and implementing appropriate safety measures related to pharmaceutical manufacturing.

Qualifications:

• Bachelors degree in Chemical Engineering, Pharmaceutical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field. A Masters or Ph.D. is a plus.
• years of experience in pharmaceutical manufacturing or related industry (entry-level, mid-career, or senior roles depending on the position).
• Strong understanding of GMP, FDA regulations, and other relevant industry standards.
• Proficiency in process design, process simulation software, and CAD tools.
• Experience in equipment design, validation, and troubleshooting in a pharmaceutical environment.
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills.
• Ability to work in a team environment and handle multiple tasks simultaneously.

Preferred Skills:

• Knowledge of process automation and control systems.
• Experience with Lean Manufacturing or Six Sigma methodologies.
• Familiarity with pharmaceutical formulation, drug production, or sterile manufacturing processes.
• Experience in regulatory filings, inspections, or audits. Responsibilitiesesponsibilities