Manufacturing Specialist Intern

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 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, 7:00am - 4:30pm. Responsibilities Maintain inspection‑readiness binders with current SOPs, training records, and emergency contacts. Assist Quality and Manufacturing Supervisors with completing batch record corrections. Support continuous improvement efforts by identifying opportunities to update SOPs, defect libraries, batch documentation, and training processes, including simplifying procedural steps through documentation improvements. Track and trend manufacturing activities to support process improvement. Coordinate and source materials for hands‑on training activities (dispensing, compounding, filling, visual inspection). Assist with organizing and maintaining in‑process and finished product samples, ensuring they are stored under the correct temperature‑controlled conditions (2-8°C, ‑20°C, ‑80°C). Assist operators in vial/syringe manufacturing activities by preparing required materials and documentation. Identify opportunities to improve training processes and simplify procedural steps through documentation updates. Organize safety instrumentation information and calibration records. Manage hazardous waste manifests and ensure return copies are received within 45 days. Inventory, inspect, and restock spill kits as needed. Perform AED inspections. Participate in weekly safety walkthroughs and monthly warehouse walkthroughs. The intern will complete all onboarding activities and provide feedback for process improvements. The intern will be trained on proper techniques and documentation in a GMP environment. Techniques will depend on the group and area. Interns will be trained on safety and quality expectations, and are expected to maintain safety and quality standards, and report safety observations according to company policy. Upon completion of the internship, incumbents will conduct individual presentations to Alcami leaders. Other duties as assigned. Qualifications Enrolled in a 4-year college or university pursuing a bachelor's degree in Engineering, Life Sciences, or a field related to the internship. Knowledge, Skills, and Abilities 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. Travel Expectations Minimal travel between local locations may be expected. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.