Computer Systems Validation Intern

Job Summary -

Support the Software Development Lifecycle Strategy of cGMP systems. These duties will include, but are not limited to: Working cross functionally on planning phase documentation, supporting CSV assessments appropriately within FDA guidance, understanding CI/CD principles in software development to a basic level, understanding the concept in the support of qualification and validation of the necessary Installation, Operational, and Performance Qualification processes, concepts of drafting summary reports alongside the Requirement Traceability Matrix and Final Validation Summary Report.

Essential Duties & Responsibilities -

Intern will perform the following under the guidance and direction of the department.

Manager/Leadership:

· Establish and maintain current Good Manufacturing Practices (cGMPs) with regards to processes and/or internal conditions leading to an aseptic environment.

· Understand the documents that are being utilized within the EDMS software system.

· Understand the concepts of the Change Management process and how it is effectively driven with the Computer System Validation principles.

· Interact and work cross functionally with different departments to gain a solid foundation of CSV principles.

· Meet timelines on documentation related to Computer System Validation and work cross functionally to meet the deadlines.

· Learn a skill set for projects under the areas of Computer System Validation assessment integration for analytical equipment, Computer System Validation gaps within integrated equipment protocols, SDLC strategies in stand-alone GxP systems, provide support in control system validation processes, understanding how GAMP fits in the pharma world, etc. 

· Draft, review, and approve GxP Assessment, IRA Assessment, FRA Assessment, IOPQ, IOPQ Summary Reports, RTM, VSR. 

· Understand URS/FRS as drafted by the System Owner. Understand the principles of the CS as that would be driven from IT. Review documentation appropriately and follow up with IT on documentation completion. 

· Open to being flexible and work on any assignment as directed and to support when needed. 

· Must be flexible on some days to stay later than usual (Coming in Early if Vendor is on-site for executions, staying in a bit later than usual at times if work has to get done or if the implementation team is still there, etc. Overtime on some days may be necessary.) 

· Support GRAM’s Core Values of Quality, Service, Collaboration, and Courage. 

· Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices. 

· Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

Education, Experience, and Training -

This internship is appropriate for a college level sophomore – senior working toward a degree in Chemistry, Pharmaceutical Engineering, Chemical/Biomedical Engineering, Biotechnology or other Life Sciences.