Job Description

This role is responsible for performing a variety of tasks related to the processing and assembly of pharmaceutical ingredients and finished products while contributing to operational excellence initiatives within a regulated manufacturing environment. The position operates and monitors general manufacturing equipment and supports the identification and implementation of process improvement opportunities to optimize resource use, minimize costs, and maintain quality standards. It involves the careful handling of raw materials as well as intermediate and finished pharmaceutical products to maintain product integrity and quality. The role contributes to the development and execution of operational excellence methodologies including lean manufacturing, continuous improvement, and efficiency enhancement programs. General maintenance activities on manufacturing equipment are performed as required to ensure operational continuity. All activities are executed in strict adherence to Standard Operating Procedures and current Good Manufacturing Practices to meet regulatory requirements. Accurate and timely completion of batch records and manufacturing documentation is maintained as a core accountability. The position participates in cross-functional team projects developing process improvement methods, solutions, and procedures to enhance program quality, cost, and scheduling.

Essential Functions:

• Operate and monitor general manufacturing equipment and support operational excellence initiatives in accordance with GMP standards and lean manufacturing principles.

• Identify and implement process improvement opportunities to optimize resource use, minimize costs, and enhance manufacturing quality and efficiency.

• Handle raw materials, intermediate products, and finished goods with care to maintain product quality and prevent contamination.

• Contribute to the development and execution of operational excellence methodologies including lean manufacturing and continuous improvement programs.

• Conduct general maintenance on manufacturing equipment and related apparatus to ensure operational readiness.

• Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements.

• Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines.

• Participate in cross-functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.

• Support area cleaning and sanitization activities to maintain a compliant and safe manufacturing environment.

Additional Responsibilities: Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 3 years or more in 3 - 6 Years

Specialized Knowledge: Licenses: