Context of the project:

Retrofitting of a client's MLD (Monoblock Linear Filling Line) system and its installation within a RABS (Restricted Access Barrier System). This project is aimed at upgrading the existing filling line to meet the latest operational, regulatory, and quality standards while ensuring a fully aseptic environment

Day-to-day tasks

Retrofitting MLD Filling Line:

• Retrofit the existing MLD filling line to meet new efficiency, capacity, and regulatory standards.
• Integrate new technologies (e.g., automation, sensors, vision systems) into the existing system to enhance performance and accuracy.
• Oversee system testing, optimization, and troubleshooting to ensure seamless operation after the retrofit.

RABS Installation:

• Coordinate the installation of the MLD filling line inside a RABS environment, ensuring full compliance with aseptic requirements and GMP standards.
• Work closely with external vendors and contractors for the design, supply, and installation of the RABS system.
• Ensure integration of the filling line with the RABS system is efficient and minimizes risk of contamination.
• Supervise commissioning, testing, and validation of the integrated system to ensure it meets all performance and regulatory requirements.

Compliance & Quality Assurance:

• Ensure all work is performed in compliance with industry regulations (e.g., FDA, EMA) and internal quality standards.
• Support the validation and qualification of the retrofitted system and RABS installation, including IQ, OQ, PQ.
• Participate in risk assessments and support root cause analysis for any issues during installation or operation.

Collaboration & Communication:

• Work closely with cross-functional teams, including production, quality control, and maintenance, to ensure project objectives are met.
• Provide regular updates and technical support to key stakeholders on the status of retrofitting and RABS installation projects.
• Assist in training operators and technicians on the new retrofitted system and RABS environment.

Must-haves requirements:

• 5+ years working in a cGMP environment, aseptic and sterile manufacturing.
• Bachelor's degree in engineering, mechanical engineering, Chemical engineering.
• Working experience/validation of aseptic filling lines (i.e. RABS) and MLD Cartridge lines (Syntegon)
• SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Expertise in aseptic filling applications, media fill validation, sterile filtration
• Experience assisting and/or performing execution activities such as FAT, SAT, IQ/OQ/PQ and CQV activities.
• Must be able to work and communicate with internal and external stakeholders (Micro, QA, Sterility Assurance and PM experience) and have good technical writing skills (SOP writing)

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