Senior Engineer, Assembly & Packaging Operation

Overview

You will play a key role in the startup and operational readiness of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Assembly and Packing Supervisor, you will support the establishment, qualification, and ongoing operation of assembly and packing processes for products manufactured through fully automated, semiautomated,

and manual assembly and packaging systems. The Engineer will be responsible for supporting and executing daily operational and inspection activities to ensure safe, efficient, compliant, and high-quality assembly and packing operations.

During the site startup phase, the position will contribute to equipment commissioning, qualification activities, process implementation, operational readiness programs, and cross-functional startup initiatives while maintaining full compliance with applicable GMP, regulatory, and quality requirements.

Responsibilities:

• Support startup, qualification, validation, and operational readiness activities for Assembly, Visual Inspection, and Packaging operations.
• Execute manufacturing and inspection activities in compliance with cGMP, SOPs, batch records, and regulatory requirements.
• Support equipment qualification, validation, troubleshooting, maintenance, and lifecycle management.
• Participate in visual inspection programs, including defect management, POD studies, QRA assessments, and qualification activities.
• Support engineering runs, media fills, process validation, PPQ, clinical manufacturing, and commercial production.
• Collaborate with cross-functional teams to support NPI, technology transfer, process improvements, and product lifecycle management.
• Investigate manufacturing issues, support CAPAs, root cause analysis, and continuous improvement initiatives.
• Prepare and maintain GMP documentation, including SOPs, batch records, protocols, reports, and training records.
• Support QMS activities, including Deviations, CAPAs, Change Controls, Risk Assessments, audits, and inspection readiness.
• Ensure compliance with FDA, EMA, PIC/S, ICH, Annex 1, customer, and cGMP requirements.
• Support training and qualification of manufacturing and inspection personnel.
• Interface with customers and stakeholders to support project execution and technology transfers.
• Ensure safe, compliant, and timely execution of assigned manufacturing and inspection activities.

Qualifications:

• Diploma or Bachelors Degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field
• 5 - 8 years+ of relevant experience in assembly and packaging drugs product manufacturing
• Working knowledge of cGMP requirements and global regulatory standards
• Familiarity with equipment qualification, process validation, engineering runs, media fills and commercial manufacturing operations
• Proficiency in manufacturing system and knowledge of quality systems