Operational Excellence Intern

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SHARP STERILE MANUFACTURING LLC

Posted 3 months ago

Internship

Lee, Massachusetts

In Person

Smart Summary

Responsibilities

Support continuous improvement and Operational Excellence initiatives within a GMP-regulated manufacturing environment. This includes conducting shop floor observations, collecting operational data, and assisting with Kaizen events to improve efficiency and quality.

Qualifications

You are currently pursuing a Bachelor's degree in a relevant field and have experience working in team-based assignments. You possess basic data organization and presentation skills, with an awareness of manufacturing regulations and a willingness to learn continuous improvement methodologies.

Must Have Skills for ATS

GMP

Lean

Kaizen

SOPs

Job Description

Position Summary

Support continuous improvement efforts within Manufacturing Operations in a GMP-regulated environment. This role works closely with Manufacturing, OpEx and supporting functions to observe processes, collect and analyze data and assist with improvement initiatives focused on efficiency, quality, safety and usability of day-to-day execution. The Operational Excellence Intern will provide hands-on exposure to manufacturing operations, Lean principles and problem-solving in a regulated pharmaceutical/manufacturing setting.

Duties and Responsibilities

  • Support OpEx and Manufacturing Operations improvement activities, including Kaizen events, rapid improvements, and standard work initiatives
  • Conduct shop floor observations to document current-state manufacturing workflows, handoffs, and opportunities for improvement
  • Collect, organize, and summarize operational data (e.g., cycle time, delays, rework, errors, waiting, motion)
  • Assist with basic problem-solving activities (e.g., identifying themes, contributing to root cause discussions)
  • Support usability improvements for manufacturing documentation (e.g., batch records, SOPs, job aids) under supervision and in alignment with document control requirements
  • Create simple visuals and summaries to support improvement efforts (process maps, charts, trackers, slide updates)
  • Participate in daily tier meetings or operational huddles as assigned; capture actions and support follow-up tracking
  • Prepare weekly updates on assigned work and a final summary of internship outcomes and learnings
  • Maintain organized files and documentation for project work per departmental expectations
  • Other duties as assigned

Regulatory Responsibilities 

Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable 

Supervisory Responsibilities

None

Experience

  • Experience working on team-based assignments (academic, lab, work, or extracurricular)
  • Basic experience organizing information and presenting results

Education

Currently pursuing a Bachelor’s degree in Chemistry, Engineering, Life Sciences, Operations, or a related field.

Knowledge, Skills & Abilities

  • Awareness that manufacturing in a regulated environment requires adherence to procedures and documentation standards.
  • Willingness to learn basic continuous improvement and problem-solving approaches.
  • Ability to organize data and observations in a clear, logical manner.
  • Effective verbal and written communication skills.
  • Ability to create simple, clear summaries and visuals.
  • Strong organizational skills and attention to detail.
  • Ability to work effectively in a manufacturing environment and collaborate with cross-functional teams.
  • Ability to observe work objectively and respectfully, focusing on the process rather than individuals.
  • Ability to ask questions, seek clarification, and escalate issues appropriately.
  • Ability to manage time and prioritize assigned tasks.

Physical Requirements 

  • Ability to sit or stand for prolonged periods of time
  • Ability to lift up to 25lbs

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SHARP STERILE MANUFACTURING LLC

Sharp Sterile Manufacturing (formerly Berkshire Sterile Manufacturing) provides the safest sterile drug products for clinical use and small scale requirements through the use of modern technology, 100% isolator-based filling lines, and a skilled staff. We offer sterile filling of syringes, vials (RTU and bulk), cartridges, custom containers, and lyophilized product. We also provide onsite analytical support, stability programs, and development services. Sharp Sterile will always be a customer-focused, quality-driven contract manufacturer of sterile injectables. We meet your changing requirements and critical deadlines. Reach out to us today for a free quote.
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