Work Schedule:

Need to be able to work 12 hour shifts (5:45 AM to 6:15 PM  OR 5:45 PM to 6:15 AM)

Need to be able to work weekends (See work week schedule below which alternates 3 days and 4 days each week)

Objectives:

Perform and document daily manufacturing operations according to SOP’s in a cGMP environment

Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)

Execute validation protocols

Create or revise cGMP documents



Accountability:

With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.

Perform basic trouble shooting

Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems

Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures.  Key documentation includes batch records, work orders, and equipment logbooks.

Executes batch records and validation protocols under supervision/direction of others

Author and review equipment use logs

Performs inventory transactions in SAP

Performs data entry into LIMS

Accountable for completing assigned trainings within required timeline and actively participate in training activities.

Stock production and cleaning supplies

Perform cleaning/sanitizing production rooms and equipment

 

Knowledge, competencies and skills:

Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred

Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred

Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus

Prior experience with lab equipment a plus

Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.