Process Validation Intern

JOB TITLE:  PROCESS VALIDATION INTERN

PRIMARY LOCATION:  GRAND RAPIDS, MI 

JOB SUMMARY: 

Support validation of cGMP pharmaceutical drug manufacturing. These duties will include, but are not limited to: oversight of document trackers, metrics and project status. Introduction and support of qualification and validation of production equipment, manufacturing process and utility principals.

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.

· Performs data entry to populate 360.articulate.com content, spreadsheets/trackers, validation protocol or report templates.

· Compiles documentation that measures project responsibilities, goals, characteristics and deliverables. Use systems such as Smartsheet and Excel to manage, populate and format data into tools to bring heightened visibility to the department functions and systems.

· Interacts with Validation and inter-departmental cross-functional team members for project execution to meet timelines within project’s scheduled completion period.

· Assure that all assignments are performed to conform to GRAM’s and cGMP requirements.

· Provide validation support to internal customers such as Technical Services, Quality Assurance , Quality Control, Manufacturing and other users of validation services.

· Trains on programs covering equipment and processes for validation and requalification.

· Learns a skill set for projects under a sponsor in the areas of Process Validation, Temperature.

. Mapping Studies, Change Part Machinability, Cycle Requalifications or client equipment testing Assists. 

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

· Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing. 

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

· 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 other tasks, projects, and duties as assigned.

EDUCATION, PRIOR EXPERIENCE, AND TRAINING:

Minimum education, experience, licenses/certificates normally required to perform duties of this position.

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