Production Technician
Core
Operate, monitor, adjust, and maintain pharmaceutical processing units and equipment to manufacture Active Pharmaceutical Ingredients (APIs) and fermentation products.
Role type
Production Technician (cGMP manufacturing)
Builds
APIs and fermentation products for clinical-to-commercial scale production
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Operating manual and automated equipment, Controlling processes from start-up to shutdown, Handling hazardous materials, Performing process sampling and testing, Collaborating on process training, Preparing shift summaries, Providing feedback for SOP improvements, Participating in quality management systems
Preferred skills
Post secondary education in applicable area, cGMP or regulated environment experience, WHMIS certification, First Aid certification
Technologies
Manual and automated fermentation equipment, Downstream purification units, Chemical synthesis and purification systems, pH/conductivity/spectrophotometry/osmometry/densometry analyzers
Responsibilities
Operating manual and automated equipment to perform Microbial Fermentations, Down Stream Purifications, Active Pharmaceutical Ingredient (API) or fine chemical manufacture. Controlling processes from start-up to shutdown, including unit operations of microbial growth, expression, recovery, filtration, chemical synthesis, and purification. Handling of hazardous materials, including acids, bases, solvents, potent compounds, biologics and APIs safely and properly. Performing process sampling and testing including pH, conductivity, spectrophotometry, osmometry, densometry, aseptic sampling and streak plating. Collaborating with other departments on process and equipment training for successful completion of manufacturing batches. Preparing shift summaries and updating excel spreadsheets with key performance and quality indicators. Providing feedback to influence continuous improvements during the review and revision of Standard Operating Procedures and other process documentation. Participating in BIOVECTRA's quality management system, focusing on the batch production records, work instructions, adherence to policies and standard operating procedures at all times. Assisting with housekeeping, equipment cleaning, general warehousing, material staging, and tanker operations as required.
Seniority
Entry to Mid-level, hands-on IC