Validation Engineer Intern

Nature and Scope

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.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.

Physical Environment and Requirements

• 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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