Manufacturing Engineer

Title

Manufacturing Line Engineer – Sterile / Vial Filling

4–8+ Years

The Manufacturing Line Engineer will be responsible for technical ownership, operational support, and continuous optimization of sterile vial filling and fill‑finish manufacturing lines. This role ensures equipment reliability, process efficiency, and compliance with cGMP and regulatory requirements during routine production and scale‑up activities.

• Provide hands‑on engineering support for aseptic vial filling, stoppering, and capping operations.
• Lead equipment setup, changeovers, troubleshooting, and optimization of fill‑finish manufacturing lines.
• Support line readiness activities for media fills, PPQ, and commercial production.
• Investigate and resolve manufacturing line issues related to equipment performance, process parameters, and product quality.
• Support commissioning, qualification, and validation (IQ/OQ/PQ) of sterile manufacturing equipment.
• Collaborate with Validation, Quality Assurance, and Manufacturing teams to address deviations, investigations, and CAPA actions.
• Support preventive maintenance, calibration activities, and spare parts management.
• Drive continuous improvement initiatives to enhance line efficiency, yield, and compliance.
• Ensure all engineering activities comply with cGMP, SOPs, and FDA regulatory requirements.

• 4–8+ years of experience as a Manufacturing, Line, or Process Engineer in sterile injectable pharmaceutical manufacturing.
• Strong hands‑on experience with aseptic vial filling and fill‑finish operations.
• Practical experience with filling, stoppering, capping, and isolator‑based fill‑finish systems.
• Solid understanding of aseptic processing, media fills, and contamination control principles.
• Experience supporting deviations, investigations, and CAPA related to manufacturing equipment and processes.
• Strong troubleshooting, root cause analysis, and problem‑solving skills.