Manufacturing Engineer

About the role

The Impact You Will Make
We are seeking a motivated and detail-oriented Manufacturing Engineer to support technical operations in our Inspection, Assembly & Packaging plant. This is a great opportunity for an entry-level engineer looking to build a strong foundation in pharmaceutical manufacturing.

Key Responsibilities

• Support achievement of safety, quality, delivery, and cost objectives for operations.
• Support the monitoring and optimization of assembly, visual inspection, labeling, and packaging processes for vials, syringes, cartridges, and other pharmaceutical products.
• Aid in developing and updating process documentation, including SOPs, batch records, and process flow diagrams.
• Collect and analyze production data to identify opportunities for improving yield, throughput, and Overall Equipment Effectiveness (OEE).
• Participate in troubleshooting manufacturing issues related to automated packaging lines, vision systems, and serialization equipment.
• Aid in the execution of validation protocols (IQ/OQ/PQ, process validation) for inspection, assembly and packaging equipment.
• Support deviation investigations, CAPA implementation, and change control processes.
• Help maintain equipment and processes in a validated state in accordance with cGMP, FDA, and EMA regulations.
• Participate in internal audits and prepare documentation for regulatory inspections.
• Collaborate with cross-functional teams (Process Development, Quality Assurance, and Production) to ensure smooth scale-up and successful product launches.
• Track actions, timelines, and deliverables to support project execution and site priorities.
• Support equipment qualification, preventive maintenance, and calibration activities.
• Participate in improving equipment reliability and uptime.
• Learn and support the operation of high-speed automated inspection systems, assembly and packaging lines.
• Participate in Lean and continuous improvement initiatives (Kaizen events, 5S, etc.).
• Prepare technical reports and presentations as required.
• Support daily production floor activities and provide engineering support during manufacturing campaigns.

Qualifications & Requirements

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.
• 2+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environment (internships or co-op experience in manufacturing is highly valued).
• Exposure to Assembly, Inspection, or Packaging processes is preferred but not required.
• Basic understanding of cGMP principles and pharmaceutical regulatory requirements.
• Strong analytical and problem-solving skills.
• Familiarity with statistical tools, root cause analysis, and Microsoft Office (Excel, Word, PowerPoint).
• Ability to read and interpret technical drawings and equipment manuals is a plus.

Preferred Qualifications

• Internship or co-op experience in pharmaceutical manufacturing or packaging operations.
• Knowledge of Lean Manufacturing or Six Sigma principles.
• Familiarity with automated inspection systems, serialization, or high-speed packaging equipment.
• Experience working in a cleanroom or GMP environment.