Aseptic Technician – II

Job Description

Job Summary:

• The main function of an Aseptic Technician is to support the manufacturing of sterile pharmaceutical products by performing tasks in controlled environments using aseptic techniques.
• A typical Aseptic Technician ensures product integrity and compliance with regulatory standards through meticulous attention to cleanliness, documentation, and process control.
• You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations.
• Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed.
• You will conduct all activities in accordance with Company policies and standard operating procedures, Client Values, and global regulatory guidelines, environmental guidelines etc.
• As an associate, your focus on the job will contribute in achieving project tasks and goals.
• Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
• It is your hard work and focus that will make Client ready to achieve new milestones and help patients across the globe.

Duties and Responsibilities:

• Execute production activities using knowledge of process equipment, systems, and manufacturing operations.
• Participate in operational qualification training and assist the Team Lead as needed.
• Ensure all activities comply with Company policies, standard operating procedures, Client Values, and global regulatory and environmental guidelines.
• Work in a structured environment using established procedures.
• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy.
• Assist in troubleshooting, technology transfer, and start-up activities.
• Applies established analytical tools to reduce cycle times and optimize production scheduling.
• Oversee technical documentation for production and process approvals, ensuring compliance with Current Good Manufacturing Practices, and manage process activities by adhering to Standard Operating Procedures.
• Assists production teams with batch paperwork and performs system transactions.
• Monitors and communicates production metrics.
• Ensures compliance with all government and company regulatory requirements.
• Verifies batch reconciliation and investigates all discrepancies immediately.
• Prepares Manufacturing Discrepancy Reports, as necessary, and escalates issues requiring Management Investigation Reports (MIRs) regarding deviations in process tasks or equipment set-up and testing.
• Partners with the Quality, Technology and Operations personnel to investigate Manufacturing Incidents applying tools as CAPA to eliminate root cause in investigating.
• Participates in continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time.
• Able to handle routine problems independently.
• Works with cross-functional experts in solving problems.
• Reviews, updates, and revises SOP’s.

Minimum Requirements:

• BA/BS degree in a science/engineering field with any years of experience, or Associate’s degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience.
• Knowledge of process equipment and manufacturing operations.
• Ability to follow standard operating procedures and regulatory guidelines.
• Basic understanding of Current Good Manufacturing Practices.
• Strong organizational skills to manage project tasks and meet deadlines.
• Technical documentation skills for production and process approvals.

Preferred Requirements:

• Experience within the pharmaceutical industry.
• Familiarity with Six Sigma or other operational excellence programs.
• Proficiency in troubleshooting and technology transfer activities.
• Strong analytical skills for process monitoring and data analysis.

Key words: 

• Biosafety cabinet, standard operating procedures (SOP’s), Chemical Engineering, general chemistry knowledge, media preparation, compliance, Lab Safety, product integrity, Research, Laboratory Equipment.