Aseptic Technician - II

Aseptic Technician - II

Pearl River, NY, United States (On-site)

Contract (9 months) Pay Rate: $26/hr on w2

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

What You Will Achieve:

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.

Role 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.