Technicien de production Albumin Purification Manufacturing Technician (Quart de nuit/Night Shift)

GRIFOLS, S.A.•Montreal, QC

37d

About The Position

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. The Manufacturing Technician will be primarily assigned to one of the following areas: Albumin Purification but will be expected to develop multi-disciplinary skills by alternating to other areas of manufacturing (Fractionation, IGIV Purification, Filling, Packaging) to assist with business demands. The Manufacturing Technician is working in a manufacturing environment regulated by cGMPs, SOPs, safety procedures and all company policies/regulations. The Manufacturing Technician performs fundamental tasks in support of more complex manufacturing operations. The tasks include, but are not limited to, cleaning and maintaining the work place so that it meets the standards for controlling bioburden levels; cleaning operating equipment per applicable procedures so that it meets the standards established to prevent product contamination and maintaining records/logs neatly and accurately and in accordance with current standard procedures. The Manufacturing Technician is expected to assist with the operating process equipment in this role. The Manufacturing Technician performs job tasks in a safe manner while following specific department safety rules.

Requirements

High school diploma or CEGEP/College diploma in Pharmaceutical Technology.
Ability to work in a fast-paced environment and manage multiple priorities
Ability to work independently as well as in a team environment
Must be able to lift, push, pull at least 15kg and wear PPE as required
Some tasks will involve working in a refrigerated environment
Bilingualism (French and English) both spoken and written. L’exigence de l’anglais est requise pour la documentation, les rapports et les interactions avec Santé Canada, FDA, et autres départements multi-disciplinaires dans l’entreprise mais basés hors-Québec et hors-Canada (Espagne, USA).
For manufacturing technicians performing visual inspection as a qualified person, the following additional qualifications are required:
Eye sight exam including color blindness testing

Nice To Haves

Preferred 1-year experience within the biopharmaceutical, pharmaceutical, healthcare industry.
Experience in clean room operation preferred.

Responsibilities

Set up, operation and cleaning the following equipment (depending on the designated manufacturing area): buffer preparation skids, centrifuge, fractionation skids and filter presses, TFF skids and columns, chromatography skids, filtration skids and filling line (within an isolator), automatic packaging line;
Set up and operation: CIP/ SIP skids, autoclaves and parts washers;
Set-up, operate and troubleshoot various packaging equipment including:
Set-up and operate multiple label verification vision systems on vial labelers and cartoners.
Set-up and operate multiple vial labelers, vial cartoners, shrink-banding machines and other equipment related to final container labeling.
Conduct periodic challenges for the various packaging systems.
Inspect packaged and pre-packaged products for possible defects (manual and semi-automatic visual inspection);
Conduct an accurate count of pre and post packaged products;
Execution of all manufacturing batch records in the designated areas based on the training completed within that area;
Escalation of all of issues potentially impacting cGMP of the respective Manufacturing area and or manufacturing process to the responsible manager immediately;
Participate in all manufacturing activities related to the assigned area including sampling (process and cleaning validation, environmental monitoring, clean utilities), in-process testing, weighing, calibration and maintenance of equipment (pH meter...);
Actively participate in writing and implementing GMP documents (SOPs, batch records) using the change control system and maintain records of all necessary information/data as per GDPs;
Execute daily, weekly and monthly cleaning in the respective manufacturing area following the applicable standard operating procedures;
Ensure all manufacturing supplies within the respective manufacturing area are maintained and replenished as required;