Description:
Typical Day:
These responsibilities include some of the following:
* Demonstrate company Values – Patient Focus, Transparency, Respect, and Integrity – in every interaction, in every work task, and with every responsibility of the job role.
* Live company's Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.
* With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks.
* Proactively work with senior staff to achieve competency in production operations.
* Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution.
* Primarily these activities are within the production suite but sometimes require out-of-suite or off-site work (i.e. FAT support).
* Monitors equipment and critical process parameters and escalate any issues or abnormalities and participating in the resulting troubleshooting activities.
* Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc).
* By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success.
· Transparently participates in investigations that are the result of safety or compliance issues.
Education Requirements:
• BS/BA degree, with cGMP manufacturing experience.
• OR an Associate’s degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience.
• OR High School degree, 1+ years of cGMP manufacturing experience.
• Open to any other scientific background education or experience.
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