DescriptionCresilon is a Brooklynbased biotechnology company that develops manufactures and markets hemostatic medical devices utilizing the companys proprietary hydrogel technology. The companys plantbased technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extendedmanual pressure. The companys current and future product lines target veterinary human trauma and human surgical applications. Cresilons mission is to save lives. Learn more about the company at.
The Production Technician I is responsible for the aseptic manufacturing of Cresilons products for the animal health industry. The Production Technician II will be trained in clean room operations aseptic techniques and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment routine sanitization of cleanroom facilities and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local State and Federal regulations including current Good Manufacturing Practices (cGMP).
- Perform line clearance of assigned production areas as required.
- Perform equipment set up and disassembly activities.
- Operate production assembly and testing equipment including heat sealers bar code scanners weighing scales tumblers autoclaves filling equipment and packaging equipment.
- Formulate fill and pouch product in accordance with SOPs.
- 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 of the manufacturing spaces.
- Perform cleaning and sterilization of manufacturing equipment.
- Perform visual inspection of components and/or product in accordance with SOPs and cGMPs.
- Perform sampling intermediate and finished goods packaging as per SOPs.
- Package and ship raw materials for sterilization.
- Perform material receiving staging material movements and material replenishment as per SOPs.
- Transport samples materials and equipment between multiple facilities.
- Complete data entry and generate reports for material inventory movements.
- Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards.
- Maintain a clean production environment during shift.
- Report all actual near misses and potential accidents for further investigation.
- Take immediate action to resolve any near miss situations.
- Assist in investigation of all actual near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently.
- Assist in project commissioning and validation activities as necessary.
- Prepare samples or prototypes as required for testing or other evaluations
- Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process.
- Complete all required trainings: Read and Understand (TM1 Computer Based Training with Quiz (TM2 Instructor Led (TM3/TM4 and OntheJob Trainings (TM5.
- Oversee training of junior employees on production processes as assigned.
- Ensure proper communication and handling over of shift duties.
- Support Environmental and Personnel Monitoring (EM/PM) activities as directed.
- Responsibilities may include other duties as assigned and as required
Requirements - HS Diploma or Equivalent with 2 years of relevant manufacturing experience in the pharmaceutical biotechnology or medical device industryOR2 or 4 year degree with 0 years of relevant experience.
- 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 become gowning qualified to work in a cleanroom environment.
- Ability to problem solve and achieve business objectives.
- Ability to adapt training approach.
- 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.
Benefits - Paid Vacation Sick & Holidays
- Medical Dental and Vision Insurance FSA: Dependent & Healthcare Commuter & Parking Benefits Long Term Disability Coverage
- Company Paid Life and ShortTerm Disability Coverage
- Work/Life Employee Assistance Program
- 401(k) & Roth Retirement Savings Planwith company match up to 5
- Monthly MetroCard Reimbursement
- $1822/hr
Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race color sex religion sexual orientation national origin disability genetic information pregnancy or any other protected characteristic as outlined by federal state or local laws.
This policy applies to all employment practices within our organization including hiring recruiting promotion termination layoff recall leave of absence compensation benefits training and apprenticeship. Cresilon makes hiring decisions based solely on qualifications merit and business needs at the time.
Required Experience:
IC