Manufacturing Production Support Operator / Production Technician
Brooklyn , NY 11215
Posted 2 weeks ago
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Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:
With the continued expansion of our manufacturing capacity, Cresilon has several job opening in our production and engineering teams. All roles are on-site in Brooklyn, NY.
Production Support Operator / Production Technician
Job Description: Support all aspects of the aseptic manufacturing and upstream/downstream processes of Cresilons products. S/he will be trained in clean room operations and aseptic techniques. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will demonstrate steady progress and must possess a willingness and ability to learn all equipment and jobs in the assigned manufacturing operations and sanitation of clean room facilities as required. Production Support Operators are responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP) and Cresilon SOPs. This is a non-exempt/hourly position. Level will depend on individual's background and experience. First, mid-shift and second production shifts are available, with priority given to second shift.
- Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, and packaging equipment.
- Troubleshoot all operating deviations and issues and coordinate with other functions when required. Report both machine and operating deviations to area supervisor or designee.
- Perform routine, preventative maintenance on equipment.
- Perform cleaning and disinfection/sterilization of the manufacturing spaces and equipment.
- Perform testing of components and product, including visual inspection.
- Assist production staff to perform in-process and finishing operations including finished goods packaging.
- Stock inventory of supplies, components, materials, etc. utilizing the Kanban system..
- Complete data entry and generate reports for material inventory movements
- Assist the Production Technicians to perform material receiving, staging, material movements, and material replenishment.
- Transport samples, materials, and equipment between multiple facilities.
- Package and ship components for processing or for final distribution.
- Complete and maintain applicable logbooks and production paperwork as required.
- Maintain a clean production environment during shift.
- Report all actual, near misses and potential accidents for further investigation.
- Assist in the investigation of all actual, near misses and potential accidents, taking immediate action to resolve any near miss situations.
- Provide information to troubleshoot and take initiative to resolve operational issues independently.
- Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process.
- Complete all required trainings and successfully follow Cresilon SOPs in accordance to Good Documentation Practice (GDP) and cGMP.
- Responsibilities may include other duties as assigned and as required.
- Education: HS Diploma or Equivalent
- Ability to read, understand, and execute written work instructions.
- Ability to complete documentation accurately.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Ability to problem solve and achieve business objectives.
- Willingness to be flexible, and open minded to new processes or changes in direction.
- Team oriented, building relationships with peers and managers in a proactive manner
- Excellent verbal and written communication skills.
- Proficient in Microsoft Office (Word, Excel, Outlook).
- Must be able to work overtime and/or second shift when needed.
- Physical Requirements
- Ability to climb, balance, stoop, reach, stand and walk.
- Ability to bend, twist, push, lift, and grasp.
- Ability to speak, listen, and understand verbal and written communication.
- Ability to pass respirator training and wear a respirator for long durations.
- Manual dexterity to perform delicate manipulations.
- Ability to perform repetitive motions, including substantial movement of wrists, hands, and or fingers.
- Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects.
- Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations
- Legal authorization to work in the United States
- Preferred Qualifications
- A background in Engineering, Science, Technology/Biotechnology.
- Experience in GMP, ISO, and FDA regulated environments
- Cleanroom experience (ISO Class 5 to 8)
- Mechanical aptitude, with prior experience in troubleshooting and repairing mechanical and/or electrical equipment.
- Competitive base salary range of $19/hr - $30/hr, depending upon job level and qualifications.
- Paid Vacation and Holidays
- Medical, Dental, and Vision Insurance
- Firm Paid Life and Short-Term Disability Coverage
- 401(k) Retirement Savings PlanI
- Monthly MTA metro-card