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Biopharm Manufacturing Assoc - Rockville Level 1 US_AGS
Job Description
Location: Rockville, MD 20852
Duration: 11 Months
Shift- Monday-Friday, 8am-5pm
Job Description:
- Basic understanding and knowledge of the following areas and ability to perform the activity with some supervisory guidance:
- Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
- Perform the set-up, operation, cleaning and break-down of process equipment.
- Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics. Operate Filter integrity devices to confirm the integrity of filters pre and post use.
- Perform process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
- Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
- Follow appropriate standard operating procedures (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.
- Follow all related safety policies and procedures and Put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
- Ability to choose a type of communication that is most effective in a given situation.
General familiarity with the following areas:
- Knowledge and application of standard ERP processes in M-ERP following global and local procedures.
- Understanding of the clients continuous improvement system and apply the GPS mindsets and behaviors.
- Knowledge and skill required to manage and use automation and emerging digital platforms.
- General knowledge of Microsoft Office Applications (Excel, Word, and Outlook)
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CEO, LanceSoft
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