Therapure Biopharma Inc. (TBI) is an integrated biopharmaceutical company that provides contract manufacturing services to clients for the development, manufacture, purification, and packaging of therapeutic proteins.
Under minimal supervision, this position will perform varied and complex fabrication, installation, operation, maintenance, calibration, and monitoring, of plant, laboratory, and production equipment, and controls relating to the operation of systems and equipment utilized in a cGMP facility.
- Inspect, test/calibrate, evaluate, and maintain the operation of critical equipment and systems in order to provide a safe and reliable facility infrastructure
- Monitor and respond to system failures, alarms and abnormal site conditions by taking appropriate corrective actions
- Ability to troubleshoot using a variety of diagnostic tools and standard equipment to isolate malfunctions and effect appropriate corrective actions without detailed instruction
- Utilize test and safety equipment as required to perform assigned tasks efficiently and safely
- Perform various preventive, corrective maintenance tasks, and calibrations on a wide variety of GMP and non-GMP production and facilities equipment such as, clean in place, purified water, water for injection, clean steam, waste neutralization, LN and mechanical refrigeration, boilers, compressed air, HVAC, pump, process tank systems, and measuring (indicating and recording) and test equipment, autoclave, lyophilizing, depyrogenation oven, parts washing, isolator, walk-in cooler, filling and capping, and chromatography equipment
- Use established internal procedures as well as industry standards, manufacturer procedures, etc. for the proper calibration and troubleshooting of measuring and test equipment
- Maintain a clean, safe work area and perform all work in accordance with SOPs, and GMP and Environmental, Health and Safety guidelines and local codes
- Responsible for daily operational checks which may include maintaining, repairing, lubricating, inspecting, cleaning and testing of equipment
- Legibly, accurately, and in detail, document work performed on work order reports
- Complete required documentation to certify the verification and calibration of measurement and test equipment
- Determine impact of required work, communicates, performs, coordinates, and/or supervises major repairs with other facilities staff/contractor and users to minimize service interruptions
- Inspects third party repairs and / or rebuilds for adherence to requirements and the quality of work
- Ability to multi-task and manage multiple and shifting priorities
- Requires a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and / or respond to call-in emergency situations
- Performs any other related duties as assigned
TECHNICAL KNOWLEDGE / EXPERIENCE:
- High School plus some formal technical education and trade Certificate of Qualification or Technologist Diploma at community college level
- 3-5 years related experience in process equipment and building services
- Good organization and communication skills
- Ability to read architectural, mechanical and electrical drawings, and P&ID’s
- Good computer skills
- Experience with packaging equipment would be a definite asset
- Experience in a cGMP environment is an asset
- Positive and flexible frame of mind to react to demanding situations
- Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
- This position requires vaccination for Hepatitis A and B
- Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shifts
While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.
NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources for assistance.
This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.Apply Now