Operations Technician

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

PRIMARY RESPONSIBILITIES (include but are not limited to)- Perform and understand detailed processes.- Perform in-process testing as required by processes and procedures utilizing instrumentation, such as cell counter.- Knowledge and understanding of test methods and interpretation of results.- Verify and enter production parameters per SOP and Batch Records.- Accurately complete documentation in batch records, logbooks, forms and other GMP documents.- Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.- Clean, prepare and assemble equipment for processing operations.- Operate and troubleshoot equipment in clean room and non-clean room environment.- Monitor environmental conditions inside and outside classified rooms.- Perform material transactions/moves/quantities/cycle counts.- Is responsible to be trained to assigned curriculum(s)- Knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.- Wear the appropriate PPE when working in manufacturing and other hazardous working environments.- Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.- Perform other work-related duties as assigned.

COMPETENCIES & PERSONAL ATTRIBUTES

Technical skills:
- Cell therapy technology knowledge is an asset.- GMP / GTP knowledge is an asset.- QMS knowledge is an asset.- Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment is required.- Knowledge of operating in clean room environment is required.- Possesses knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.- Able to assist or may lead troubleshooting of routine manufacturing equipment and processes and notifies supervision of any issues.- Identifies discrepancies or trends that might need additional attention and notifies supervision.- Work with blood, blood products and chemicals.- Professional English skills

Personal skills:
- Excellent organizational skills with a strong sense of priorities.- Flexible and comfortable in a fast-changing environment.- Good problem solving and time management skills.- Self-started while being able to act autonomously.- Team player and collaborative mindset.- Customer and solution oriented.- Demonstrated interest to learn.

QUALIFICATIONS AND EDUCATION REQUIREMENTS- Bachelor Degree in Chemistry, Biology or a related field of study is desirable. BS Preferred.- 8 years’ experience in Cell Processing or 5 years pharmaceutical manufacturing in a GMP facility can be substituted for degree