Stagiaire, Opérations De Fabrication & Validation IGIV Manufacturing Operations & Validation Intern

Stagiaire, Opérations De Fabrication & Validation Igiv Manufacturing Operations & Validation Intern

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Title: Manufacturing Operations and Validation Intern - Gamunex

Reports to: Director, Validation

Duration: 8-12 months

Start Date: September 8, 2025

Position Summary: The Manufacturing Operations & Validation Intern's principal responsibility is to support both commissioning and validation activities as well as Good Manufacturing Practice (GMP) operations.

Key Duties and Responsibilities:

• Assist Validation Specialists in the commissioning and qualification of manufacturing equipment and cleanroom facilities.
• Participate in the development of validation protocols (IQ/OQ/PQ) and documentation in compliance with GMP standards by verifying drawings, components, parts, P&ID, testing and protocol execution, and data analysis.
• Participate in routine GMP manufacturing operations, including cleaning and sanitization of equipment and production areas. Preparation of materials and equipment for production.
• Contribute to the drafting and revision of 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 accordance with regulatory requirements.
• Adhere to all safety and compliance protocols.
• Demonstrate knowledge of proper aseptic techniques.
• Communicate effectively and promptly, escalate any issues that require management decisions.
• Demonstrate high levels of values and integrity.
• Demonstrate responsibility and accountability in a team environment.

Qualifications:

• Currently enrolled in an undergraduate program in Biotechnology, Chemical or Mechanical Engineering, Life Sciences, or a related field.
• Strong interest in pharmaceutical manufacturing and regulatory compliance.
• GPA of 3.00 or higher required.
• Available for a minimum of 8 months full time internship in Montréal, Québec from September 2025 to at least end of April 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 is preferred.
• Must be able to work independently with minimum supervision and use good judgment.
• Able to keep neat, accurate and complete records and logs.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
• Ability to meet deadlines, and handle an ever changing, fast paced critical work environment.
• Strong organizational skills, analytical and problem-solving skills. Ability to analyse details and perform structured decision-making on a daily basis.
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Experience in creating reports in Words and Excel. Microsoft Project and Visio a plus.
• Ability to lift or push up to 25 pounds.
• Good oral and written communication skills and good interpersonal skills.
• Bilingual in both French and English preferred.

What You'll Gain:

• Practical experience in a GMP-regulated environment.
• Exposure to industry-standard validation and commissioning processes.
• Understanding of pharmaceutical manufacturing operations and quality systems.
• Experience in SOP development and documentation practices.
• Mentorship from experienced professionals in the field.