Equipment Specialist

Reference no: R

Position title:

Equipment Specialist

Duration:
Fixed Term Contract (24 months)

Location:

Toronto, ON

• Ensures smooth operation of influenza manufacturing processes.
• Reviews documentation for completion and accuracy as per cGMP guidelines (i.e. eLogbooks, eBRs, monitoring charts, etc.)
• Perform cleaning and ensure that clean rooms, equipment, and production instruments are maintained in good condition to maintain quality compliance requirements.
• Order and ensure adequate chemicals, materials, and spare parts are available for routine operations.
• Train and ensure operational staff comply to cGMP, HSE, and Quality requirements.
• Participate in daily +QDCI (or equivalent)
• Co-ordinate with units within department (MWS, downstream), other outside departments (Maintenance, Manufacturing Technology, QC, QO, etc.) and external vendors to ensure timely completion of production support activities.

• Works to prepare assigned areas for the oncoming shifts and resolves production issues.
• Sets-up production lines prior to start-up of each batch.
• Ability to troubleshoot quickly upon startup of production equipment to rectify or propose timely solution to keep production on schedule.
• Perform minor repairs / part replacements on production machines and/or equipment when a malfunction has been detected.
• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
• For unplanned work communicate with TS Maintenance and create notifications in SAP for Maintenance work orders (or any relevant system).
• Ensures the completion of cleaning and sanitation post-troubleshooting activities, as required.

• Performs SAP shop floor operational equipment preventive maintenance activities and makes repairs to production equipment or other area equipment as per procedures.
• Maintain all production equipment by complying with operations preventative maintenance and some calibration schedules.
• Order from maintained inventory of spare parts and consumables required for maintenance activities.
• Perform visual inspection of equipment for contamination and damage after maintenance activities.
• Support planned maintenance activities & perform post-inspection test for proper equipment functionality.
• Ensure maintenance activities are performed in an ergonomic way, escape any potential hazards, and help develop proposed solutions.
• Support utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.

• Complete quality documentation (eBRs, eLogbooks, Training Matrix, SAP or equivalent work orders etc.) accurately and in a timely manner.
• Create Notifications for Maintenance SAP (or relevant system) work orders, for future planned work.
• Assist with deviation investigations and implementation of CAPAs.
• Request materials from MWS and ensure timely receipt for Upstream and Downstream operations.
• Ensure transactions are done in a timely, accurate manner.
• Trains and orients new team members as assigned in multiple areas.

• Assist with implementation of facility, equipment, and process improvement projects.
• Perform activities for qualification and validation as required.
• Assist with updating procedures and corresponding documentation (i.e., SOPs, SWIs, vendor documents, equipment documents etc.) for improving processes in accordance with change control policies.
• Ensure production area is kept in a tidy, GMP manner by implementing lean methodologies.
• Ensure production areas are inspection ready at all times.
• Support internal/external audits & inspections.
• Propose improvement ideas for equipment and processes based on technical knowledge.

• Ensure routine HSE checks and inspections are completed in timely manner.
• Ensure equipment is operated and maintenance activities are performed as per HSE guidelines.
• Support culture of HSE in department and support HSE initiatives.
• Ensure operators are equipped and use proper PPE when performing tasks.
• Ensure cleaning chemicals and equipment are stored and used as per HSE requirements and has SDS available.
• Follow and adhere to equipment Lockout/ Tagout and De-energizing procedures when required.

• Minimum three (3) years College Diploma (Engineering, Science, Biotechnology or related).
• Minimum of eighteen (18) months of previous relevant work experience.
• Preferred three (3) years College Diploma (Engineering, Science, Biotechnology or Equivalent) plus a minimum of two (2) years of previous relevant work experience.
• Sound knowledge of Upstream, Downstream and MWS equipment and…