The posting
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.
The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s 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 SOP’s and cGMP’s.
- 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 On-the-Job 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 industry OR 2 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 Short-Term Disability Coverage
- Work/Life Employee Assistance Program
- 401(k) & Roth Retirement Savings Plan with company match up to 5%
- Monthly MetroCard Reimbursement
- $20-24/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.
