Stagiaire En Opérations De Fabrication & Validation - Manufacturing Operations & Validation Intern

Stagiaire en Opérations de Fabrication & Validation - Manufacturing Operations & Validation Intern

Location: Montreal, CA

Contract Type: Internship

Area: Research & Development

Position Title: Manufacturing Operations & Validation Intern - Fractionation

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, and contributing 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 (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).

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.