Validation Engineer Intern

American Regent, Inc.New Albany, OH
1dOnsite

About The Position

Under direct supervision, the Validation Engineering Intern supports validation activities within a pharmaceutical manufacturing environment, including documentation support, data collection, and data entry. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Support preparation, review, and maintenance of validation documentation (Validation protocols, reports, etc..). Assist in execution of validation activities for equipment, utilities, and processes. Perform data collection, data entry, and basic analysis of validation results. Support document control and archival in compliance with GMP requirements. Assist in risk assessments, discrepancy tracking, and change control documentation. Prepare reports, summaries, and presentations of project outcomes. Collaborate with cross-functional teams (Engineering, QA, Manufacturing etc.). Prepare a presentation of project results at the end of the internship. Perform any other tasks/duties as assigned by management.

Requirements

  • 1+ years of college level courses pursuing a degree in business administration or equivalent, required.
  • Proficiency in Microsoft Office Suite and other programs as needed.
  • Ability to work 40 hrs/week during the summer internship program onsite in a Manufacturing environment.
  • Excellent organizational and communication skills (both written and verbal).
  • Ability to work both independently and in a team environment.
  • Ability to work overtime as needed.
  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
  • PPE and Respirators are essential for the health and safety of employees.
  • Employee must be able to occasionally lift and/or move up to 25 pounds.

Responsibilities

  • Support preparation, review, and maintenance of validation documentation (Validation protocols, reports, etc..).
  • Assist in execution of validation activities for equipment, utilities, and processes.
  • Perform data collection, data entry, and basic analysis of validation results.
  • Support document control and archival in compliance with GMP requirements.
  • Assist in risk assessments, discrepancy tracking, and change control documentation.
  • Prepare reports, summaries, and presentations of project outcomes.
  • Collaborate with cross-functional teams (Engineering, QA, Manufacturing etc.).
  • Prepare a presentation of project results at the end of the internship.
  • Perform any other tasks/duties as assigned by management.
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