Cryogenic Process Associate
About The Position
The Cryogenic Process Associate/Specialist assists in the execution of drug substance freezing, drug substance and QC sample shipments according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs). This position responsibility consists of performing operational and warehousing activities in the site Cryogenic facility. Activities include the freeze –thaw processing steps and packaging- shipping of bulk drug substances in accordance with the defined process parameters and the business requirements of the Devens site. Scope of position requires some, but limited activities, in walk-in refrigerators and freezers (personnel protection provided). Upon completion of training, person will demonstrate a thorough understanding of Good Manufacturing Practices, and a working knowledge of the facility and equipment. A background in automated business and process control systems is required. An operator is expected to provide process movements, troubleshooting, and maintenance support activities during normal business hours. Operators Perform inventory control (SAP) transactions as required for material movement updates, ordering supplies through both manual and electronic systems and routine cleaning operations. Operators are required to initiate ongoing communications using appropriate communication channels to organize information with clarity. This is a 1st shift position with the occasional need to be called in during off hours.
Requirements
- Associates degree is preferred with a minimum of 2 years of pertinent experience.
- Comprehensive knowledge of process operations as well as material handling and warehousing is required.
- Demonstrated ability to operate and troubleshoot mechanical equipment.
- Ability to operate and maintain material handling equipment and other site vehicles is required.
- Excellent understanding of relevant cGMP issues such as batch record recording review, procedure writing and revisions, housekeeping, and environmental control is required.
- A background in automated business and process control systems is required.
Responsibilities
- Performing operational and warehousing activities in the site Cryogenic facility.
- Freeze –thaw processing steps and packaging- shipping of bulk drug substances.
- Walk-in refrigerators and freezers operations (personnel protection provided).
- Demonstrate a thorough understanding of Good Manufacturing Practices, and a working knowledge of the facility and equipment.
- Provide process movements, troubleshooting, and maintenance support activities.
- Perform inventory control (SAP) transactions for material movement updates.
- Order supplies through both manual and electronic systems.
- Perform routine cleaning operations.
- Initiate ongoing communications using appropriate communication channels to organize information with clarity.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
