The Scientist I core responsibilities include designing validation sampling/test plans, performing development studies, generating validation protocols, executing validation studies, resolving technical issues encountered during study execution, and preparing validation final reports. This position conducts and participates in projects that are complex and scientifically demanding. This position has involvement in all core areas of biopharmaceutical validation: cleaning, sterilization, process, manufacturing/analytical equipment, and utility system qualifications. The individual is expected to work independently or in collaboration with others. Projects are assigned by management. Excellent written skills is essential.
The Scientist-I also supports technology transfer activities tracked in the site change control system, method validation/method transfer, filter validation, shipping qualification, and FAT/SAT/Commissioning activities. The individual may assist with validation master plans. The individual is expected to possess strong technical skills and experience with biopharmaceutical unit operations and equipment.
The individual may also be responsible for developing project plans and coordinating and reviewing work performed by contract staff.
The position may require off-shift and weekend work. On-call support is required 1 in 10 days. The position may require limited travel (<10%).