Validation Engineer in North York Ontario, Canada

Were hiring a Validation Engineer for our client, who is a large pharmaceutical company, to join their team. This is a 1-year contract.



About this role

Responsibilities

  • Review equipment or load modifications and assess impact on validation status;
  • Ensure materials of construction, sizes, and quantities are compatible with proposed thermal processing;
  • Provide recommendations for qualification / validation and complete change control actions, if required;
  • Generate qualification and re-validation protocols for sterilization, depyrogenation and freeze-drying equipment and load items in accordance with site procedures;
  • Identify sterile boundary of equipment or load items (ie. interpretation of P&ID for SIP systems) and apply acceptable challenge criteria in accordance with site procedures and applicable literature references to meet end user needs;
  • Coordinate (with equipment owner) and schedule execution of qualification and validation activities in accordance with SAP preventative maintenance scheduling and project timelines;
  • Review previous validation and qualification studies, relevant thermal assessments, users SOP's, and develop an acceptable qualification/re-validation plan;
  • Perform pre-qualification or re-validation checklists and ensure that all criteria have been met prior to study execution.
  • Co-ordinate with various departments for scheduling of personnel and equipment;
  • Understand and adhere to area equipment, personnel flows, and medical clearance of the area (classified or unclassified) in which the equipment resides;
  • Generate, calibrate or order all required qualification/re-validation testing materials (this includes but is not limited to preparation of temperature sensors, scheduling and ordering tests in SAP or with external testing labs, calibration of data logger, etc.);
  • Liaise with end user and provide direction to validation support staff prior to and during protocol execution (execution studies include but are not limited to sterilizing and decontamination autoclaves, SIP bioreactors, vial washers, isolators, tunnels, etc.);
  • Perform, analyze and review raw data and compile and present information in the approved format;
  • Resolve all non-conformances (troubleshooting), system change requests and protocol change requests prior to completion of execution and submit raw data package for quality audit;
  • Resolve all quality audit citations;
  • Prepare qualification/re-validation reports in accordance with qualification/re-validation timelines and for regulatory submissions;
  • Liaise with end user upon completion of studies and communicate all recommendations, if required;
  • Ensure maintenance and supply of testing materials, lab equipment and consumables;
  • Monitor contractor use of lab materials and assure adherence to laboratory rules (ie. PPE, reagents, gases, etc.);
  • Review contractor raw data associated with calibration and verification of data loggers;
  • Update departmental SOPs, perform gap assessments, complete CAPA actions, change control coordination and change control actions;
  • Maintain training records and update training modules (when applicable) to remain compliant;
  • Support inspection activities.


About you

Requirements

  • Diploma in Industrial Biotechnology or Industrial Microbiology;
  • Knowledge of engineering principles, bioprocessing, and P&IDs;
  • Required for the understanding of unit operation, identification of sterile boundaries, and for troubleshooting performance and sterilization issues;
  • Identification of safety risks;
  • Technical writing skills writing qualification protocols, reports, SOPs, and thermal assessments;
  • Chemistry knowledge for understanding chemical disinfection (ie. vaporized hydrogen peroxide in isolators, etc.) and laboratory handling of compressed gases and chemical reagents;
  • Microbiology experience for the safe handling of biohazardous material and understanding / application of biological kill ideologies;
  • Thermodynamics knowledge required to understand and apply physical lethality ideologies;
  • Basic knowledge of computer software (e.g. word processing, spreadsheets, drawing applications) for documentation practices (e.g. Protocols, Reports, CAPA's and CCR's);
  • Knowledge of cGMPs, PDA, USP, CFR, ISO and other such guidelines as applicable to maintain industrial compliance;
  • Specialized HSE knowledge (ie. confined space, fall arrest, etc);
  • Required for all activities pertaining to execution of qualification/re-validation of equipment;
  • Ability to work in variable conditions near extreme temperatures.


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