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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in operating and maintaining manufacturing equipment in a cGMP-regulated environment, with strong capabilities in documentation and compliance. Proficient in performing quality inspections and maintaining cleanroom standards while effectively collaborating in a team-oriented setting.
Highest-signal resume keywords
CGMP ComplianceManufacturing Equipment OperationCleanroom ExperienceBilingual in French and EnglishPharmaceutical Technology Diploma
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Buffer PreparationCentrifuge OperationChromatographyFiltrationPackaging Equipment TroubleshootingVisual InspectionEnvironmental MonitoringEquipment MaintenanceBatch Record ExecutionChange Control Documentation
Soft Skills
Team CollaborationIndependent WorkTime ManagementAdaptabilityAttention to Detail
Tools & Technologies
CIP/SIP SkidsAutoclavesLabel Verification SystemsVial LabelersShrink-Banding Machines
Industry Keywords
BiopharmaceuticalPharmaceuticalHealthcareSOPPPEGDP ComplianceHealth CanadaFDAManufacturing RecordsQuality Control
About the role
Key responsibilities & impact- Primarily work in the Filling area while developing multidisciplinary skills through rotation across Fractionation, Albumin Purification, IGIV Purification, and Packaging.
- Work in a cGMP-, SOP-, safety procedure-, and company policy-regulated manufacturing environment.
- Clean and maintain workplaces and operating equipment to control bioburden and prevent product contamination.
- Maintain accurate manufacturing records and logs.
- Assist with operating process equipment safely.
- Set up, operate, and clean buffer preparation skids, centrifuges, fractionation skids, filter presses, TFF skids and columns, chromatography skids, filtration skids, filling lines within an isolator, and automatic packaging lines.
- Set up and operate CIP/SIP skids, autoclaves, and parts washers.
- Set up, operate, and troubleshoot packaging equipment, label verification vision systems, vial labelers, vial cartoners, shrink-banding machines, and related labeling equipment.
- Conduct periodic packaging-system challenges.
- Inspect packaged and pre-packaged products for defects and accurately count products before and after packaging.
- Execute manufacturing batch records in designated areas.
- Immediately escalate issues potentially affecting cGMP or manufacturing processes.
- Participate in sampling, validation, environmental monitoring, clean utilities, in-process testing, weighing, calibration, and equipment maintenance.
- Help write and implement GMP documents using the change control system and maintain GDP-compliant records.
- Perform daily, weekly, and monthly cleaning.
- Maintain and replenish manufacturing supplies.
Requirements
What you’ll need- High school diploma or CEGEP/college diploma in Pharmaceutical Technology.
- One year of experience in the biopharmaceutical, pharmaceutical, or healthcare industry is preferred.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Ability to work independently and as part of a team.
- Must be able to lift, push, and pull at least 15 kg and wear PPE as required.
- Some tasks involve working in a refrigerated environment.
- Experience working in a cleanroom is preferred.
- Bilingual in French and English, both spoken and written.
- English is required for documentation, reports, and interactions with Health Canada, the FDA, and multidisciplinary departments based outside Quebec and Canada.
- For manufacturing technicians qualified to perform visual inspection: eyesight examination, including color-blindness testing.
