Manufacturing Operations Intern, Fractionation

Role Overview

• Assist validation specialists with commissioning and qualification of manufacturing equipment and cleanrooms.
• Participate in routine manufacturing operations in accordance with GMP, including:
• Cleaning and disinfecting equipment and production areas.
• Preparing materials and equipment for production.
• Contribute to drafting and reviewing standard operating procedures (SOPs) related to manufacturing and cleaning processes.
• Collaborate with cross-functional teams including Quality Assurance, Quality Control, Engineering and Production.
• Maintain accurate and detailed records in compliance with regulatory requirements.
• Adhere to all safety and compliance protocols.
• Demonstrate knowledge of appropriate aseptic techniques.
• Communicate effectively and promptly, escalating issues that require management decisions.
• Exhibit strong values and integrity.
• Show accountability within a team environment.

Requirements

• Currently enrolled in a university program in Biotechnology, Chemical or Mechanical Engineering, Life Sciences, or a related field.
• Strong interest in pharmaceutical manufacturing and regulatory compliance.
• Cumulative GPA of 3.00 or higher required.
• Available for a full-time internship of at least 8 months in Montreal, Quebec, from May 2026 through at least December 2026.
• Excellent attention to detail and organizational skills.
• Ability to work in a cleanroom environment and follow strict procedures.
• Experience in an FDA-regulated manufacturing facility—pharmaceutical, biologics, biotech, or medical device industry preferred.
• Able to work independently with minimal supervision and exercise sound judgment.
• Able to maintain neat, accurate and complete records and documentation.
• Strong interpersonal skills and ability to interact professionally with all levels of staff.
• Ability to meet deadlines and manage a fast-paced, critical work environment.
• Strong organizational, analytical and problem-solving skills. Ability to analyze details and make structured decisions day-to-day.
• Proficient in Microsoft Office, including Word, Excel and PowerPoint. Experience creating reports in Word and Excel. Microsoft Project and Visio are assets.
• Ability to lift or push up to 25 pounds.
• Good verbal and written communication skills and strong interpersonal skills.
• Bilingual in French and English preferred.

Benefits

• Hands-on experience in a GMP-regulated environment.
• Exposure to industry-standard commissioning and validation processes.
• Understanding of pharmaceutical manufacturing operations and quality systems.
• Experience developing standard operating procedures and good documentation practices.
• Mentoring by experienced industry professionals.