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About the Role

Cresilon is seeking a Production Technician I/II to perform aseptic manufacturing of medical devices. This role involves operating processing equipment, sanitizing facilities, and ensuring product quality and compliance with cGMP regulations. The position offers opportunities for training in cleanroom operations and aseptic techniques, with a mission to save lives.

Responsibilities

• Perform line clearance of assigned production areas.
• Set up and disassemble equipment.
• Operate production, assembly, and testing equipment including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling, and packaging equipment.
• Formulate, fill, and pouch product in accordance with SOPs.
• Troubleshoot operating deviations and issues, coordinating with other functions as needed.
• Report machine and operating deviations to the area supervisor.
• Perform routine and preventative maintenance on equipment.
• Clean and disinfect manufacturing spaces.
• Clean and sterilize manufacturing equipment.
• Perform visual inspection of components and/or product.
• Perform sampling, intermediate, and finished goods packaging.
• Package and ship raw materials for sterilization.
• Perform material receiving, staging, movements, and replenishment.
• Transport samples, materials, and equipment between facilities.
• Complete data entry and generate reports for material inventory movements.
• Complete and maintain logbooks and batch record paperwork.
• Maintain a clean production environment.
• Report accidents and near misses for investigation.
• Take immediate action to resolve near miss situations.
• Assist in the investigation of accidents and near misses.
• Provide information to troubleshoot and resolve operational issues independently.
• Assist in project commissioning and validation activities.
• Prepare samples or prototypes for testing or evaluations.
• Monitor plant status and liaise with colleagues to ensure manufacturing process continuity.
• Complete all required trainings.
• Oversee training of junior employees on production processes.
• Ensure proper communication and handover of shift duties.
• Support Environmental and Personnel Monitoring (EM/PM) activities.
• Perform other duties as assigned.

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 proactively.
• 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.

Skills

• Aseptic manufacturing
• Clean room operations
• Aseptic techniques
• Gowning qualifications
• Operating processing equipment
• Sanitization
• Manual cleaning
• cGMP compliance
• Microsoft Office (Word, Excel, Outlook)

Location

• Brooklyn

Work Type

• Full-time
• Overtime

Experience Level

• 2+ years of relevant manufacturing experience (with HS Diploma)
• 0+ years of relevant experience (with 2 or 4 year degree)

Education Level

• HS Diploma or Equivalent
• 2 or 4 year degree

Salary/Compensations

• $20-24/hr

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

About the Company

• Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing 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.
• 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.

Equal Opportunity

• 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.