Cleanroom Production Technician I

About the Company

Hyacinth Proteins is advancing the development of agriculturally derived bioactive proteins through novel technology, processes, and equipment innovation. This ‘next-gen’ technology will position Hyacinth Proteins as a leader in the manufacture of ultra-pure, pharmaceutical grade bioactive proteins.

Job Description

Hyacinth Proteins seeks highly independent, entrepreneurial individuals who will assist in developing a commercialization-focused, industrial-scale production operation supported by novel protein research.

The Cleanroom Production Technician I will join a growing team in this early-stage company to apply expertise in technical production of dairy-derived proteins. They will support the Quality Assurance department with the readiness and operation of the Hyacinth Proteins production facility.

The position involves assisting in cleanroom operations, ensuring adherence to established processes and procedures, and contributing to the overall quality of the products. The role requires attention to detail and a commitment to following precise cleanroom procedures to guarantee the efficacy and safety of pharmaceutical products.

The position is located in Twin Falls, ID and will report to the Vice President of Protein Manufacturing.

Specific responsibilities include:

• Perform the setup, operation, and sanitation of all production facilities and related manufacturing equipment
• Operate, maintain, and troubleshoot process equipment utilized in the facility, and perform equipment adjustments as needed
• Perform precise measurements to accurately add chemicals, buffers or reagents during processing
• Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 7 Clean room operations
• Responsible for accurately maintaining accurate records, required logs, books, and other procedures to comply with regulatory requirements
• Interface with QA/QC/Material departments during the course of work to coordinate inspections and efficient flow of subassemblies and completed product
• Enter and record production activities in appropriate quality systems
• Responsible for handling, decontamination, and cleaning of production supplies, instruments, and equipment to support all cleanroom production related activities
• Responsible for reporting all discrepancies to the Quality Assurance Manager
• Support department and plant Safety goals by continuously demonstrating safe behavior
• Maintain a clean and orderly work area
• Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements
• Perform other manufacturing activities as assigned by the VP of Protein Manufacturing
• May use lyophilizers, fluid bed dryers, autoclaves, vacuum pumps, pH meters, thermometers, balances (scales), water bath circulators, sonicators, mixers, centrifuge, blenders, air gun, temperature recorders, refrigerators, freezers, pallet jacks, electrical equipment, analytical equipment, cleaning chemicals, acids and bases and related cleanroom production equipment
• While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type
• The employee must be able to stand for 8 hours, or more as needed and lift up to 60lbs
• Manage and complete all required documentation related to production, compliance, audits and analytical analyses (COA and SDS)
• Support microbial sanitation testing throughout the production facility as required by any and all standards to include water quality, surfaces and air sampling
• Assure that all facilities are adherent to Hazard Analysis Critical Control Point (HACCP), Hazard Analysis & Risk-based Preventive Controls (HARPC), Sanitation Standard Operating Procedures (SSOPs), formulations, & finished product consistently meet specifications
• Must be comfortable wearing ISO7 cleanroom garments
• Ability to apply statistical process control concepts and generally evaluate product quality during processing
• Ability to communicate effectively in written and oral form with Quality Assurance staff
• Must be able perform the essential job functions of this position with or without reasonable accommodation

Qualifications

· H.S. or higher with experience in nutraceutical, medical device or pharmaceutical cleanroom manufacturing preferred

· 5 years’ experience, preferably in a biopharmaceutical setting

· Experience with the following compliance processes: Hazard Analysis and Critical Control Points (HACCP), United States Department of Agriculture (USDA), Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Current Good Manufacturing Practice (cGMP)

· Experience with cleanroom filtration equipment and technology such as Ultrafiltration, various biologic and bioburden filters, chemical tanks and sanitation chemicals

· Strong analytical and critical thinking skills to proactively identify and define problems, collect data, establish facts and draw valid conclusions through reporting

Compensation

Hours

• Full-time with ability to work overtime as needed.

Pay

• TBD hourly rate

Bonus

• A yearly bonus will be developed based on the success of the company as defined by management

Benefits

• Paid time off

o 10 days of general use

o Federal Holidays: New Years Day, Memorial Day, Independence Day, Labor Day, Veterans Day (5 days)

o The week of Thanksgiving (5 week days)

o The last 2 weeks of the calendar year (10 week days), unless otherwise noted

Pay: From $20.00 per hour

Expected hours: 40 per week

Work Location: In person

Salary : $20