Job Description

JOB DESCRIPTION / ROLE PROFILE

OBJECTIVES: (Briefly summarise the overall purpose of the position.  Objectives should be written in 3 – 4 bulleted statements). •             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

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.  •             Must have excellent written and oral communication skills •             Must be team and detail-oriented and able to work in a fast-paced environment. •             Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT) •             Must be able to read and understand English  

ACCOUNTABILITY : (Describe the primary duties and responsibilities of the job.  Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified). •             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 •             Other duties as assigned

Qualifications null Additional Information

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