Aseptic Manufacturing Technician

2 months ago

Brooklyn, New York, United States Cresilon, Inc. Full time
Job Overview

Cresilon, Inc. is a pioneering biotechnology firm dedicated to the creation, production, and distribution of hemostatic medical devices that leverage our innovative hydrogel technology. Our plant-based solutions have transformed the conventional methods of halting traumatic and surgical bleeding, achieving results in mere seconds without prolonged manual pressure. Our product offerings cater to veterinary, human trauma, and surgical needs, with a mission centered on saving lives.

Position Summary

The Aseptic Manufacturing Technician plays a crucial role in the sterile production of Cresilon's offerings for the animal health sector. This position requires training in cleanroom procedures and aseptic methods, with a focus on successfully completing gowning qualifications. Responsibilities include operating both basic and advanced processing machinery, maintaining cleanliness in the cleanroom environment, and performing manual equipment cleaning.

Key Responsibilities
  • Conduct line clearance in designated production zones as necessary.
  • Manage equipment setup and disassembly tasks.
  • Operate various production and testing machinery, including heat sealers, barcode scanners, and filling equipment.
  • Formulate, fill, and package products in accordance with standard operating procedures (SOPs).
  • Identify and troubleshoot operational deviations, collaborating with other departments as needed.
  • Document any machine and operational discrepancies to the area supervisor.
  • Perform routine maintenance on production equipment.
  • Ensure thorough cleaning and disinfection of manufacturing areas.
  • Inspect components and products visually, adhering to SOPs and current Good Manufacturing Practices (cGMP).
  • Handle material receiving, staging, and replenishment in line with SOPs.
  • Transport samples and materials between facilities as required.
  • Maintain accurate inventory records and generate reports.
  • Keep a tidy production environment throughout the shift.
  • Report all incidents and near misses for further investigation.
  • Assist in the training of junior staff on production processes.
  • Support Environmental and Personnel Monitoring (EM/PM) activities as directed.
  • Other duties may be assigned as necessary.
Qualifications
  • High School Diploma or equivalent with a minimum of 2 years of relevant experience in the pharmaceutical, biotechnology, or medical device sectors, or a 2 or 4-year degree with no prior experience.
  • Proficient in reading and executing written instructions.
  • Strong documentation skills and attention to detail.
  • Basic mathematical skills for measurements and calculations.
  • Ability to achieve gowning qualifications for cleanroom operations.
  • Problem-solving skills with a focus on achieving business objectives.
  • Adaptability to new processes and changes in direction.
  • Team-oriented with a proactive approach to building relationships.
  • Excellent verbal and written communication abilities.
  • Familiarity with Microsoft Office Suite (Word, Excel, Outlook).
  • Willingness to work overtime or second shifts as required.
Benefits
  • Paid time off including vacation, sick leave, and holidays.
  • Comprehensive medical, dental, and vision insurance options.
  • Company-paid life and short-term disability insurance.
  • Employee assistance programs for work-life balance.
  • 401(k) plan with company matching contributions.
  • Monthly transportation reimbursement.
  • Hourly wage range of $18-22.

Cresilon, Inc. is an equal opportunity employer committed to fostering diversity and inclusion in the workplace. We prohibit discrimination and harassment based on any protected characteristic as outlined by applicable laws.

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