Validation Intern

Alcami Corporation • Charleston, SC

12d • Onsite

About The Position

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Validation Intern will gain exposure to the full validation lifecycle, supporting the execution of GMP activities that directly contribute to regulatory compliance and operational excellence. They will assist in organizing and onboarding documentation within the EDMS, playing a key role in preparing critical records for FDA audit readiness. This role offers an opportunity to build strong technical and quality‑system skills while contributing to meaningful, real‑world projects. The Alcami Intern will complete company onboarding activities and provide feedback to ensure our onboarding program is efficient and engaging. Interns will develop their skills and increase their knowledge of CDMO regulations and activities while working in a world-class pharmaceutical environment. The Alcami Intern Program is a minimum 10-week paid program. Alcami interns are provided hands-on work experience building upon knowledge and skills learned in the classroom. Interns work side-by-side industry leaders in a dynamic, fast-paced environment who are passionate about being part of a team developing life-saving drugs around the world. The program concludes with individual presentations to Alcami leaders. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Requirements

• Enrolled in a 4-year college or university pursuing a bachelor’s degree in a field related to the internship.
• Good verbal and written communication and documentation skills required.
• Strong detail orientation and organizational skills required.
• Good problem-solving and basic trouble-shooting ability required.
• Willingness to collaborate with other team members.
• Good knowledge of Microsoft Office including Word, Excel, and PowerPoint.
• Follows all safety policies and leads by example a safety-first culture.
• Produces high quality work products with a focus on first time right.
• Complies with the company code of conduct, policies, and regulatory standards.

Responsibilities

• Apply 5S principles to organize validation workspaces and digital directories, improving efficiency and visibility.
• Maintain tracking lists and inventories to support document flow through review, approval, and archival in the EDMS.
• Scan, archive, and retrieve validation records to support regulated documentation needs and audit readiness.
• Prepare materials and maintain inventories of equipment, software versions, qualification status, and consumables used in validation activities.
• Contribute to continuous improvement by updating templates, guides, checklists, and workflow tools to ensure consistent, audit‑ready validation packages.
• Complete onboarding, GDP, GMP, safety, and validation‑specific training, and learn proper techniques and documentation practices in a GMP environment, while maintaining all required safety, quality, and documentation standards.
• Provide feedback on onboarding and process improvements throughout the internship.
• Deliver a final presentation to company leadership summarizing internship contributions.
• Other duties as assigned.

What This Job Offers

• Career Level: Intern
• Number of Employees: 1-10 employees