Job Description

A career at Resilience is more than just a job - its an opportunity to change the future.Resilience is a technology-focused biomanufacturing company thats changing the way medicine is made. Were building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.For more information, please visitThis is an 18-month Fixed-Term Contract position.The hours are 11:00am - 7:00pm (Monday - Friday), weekends as needed.Position Summary & Responsibilities:

• Act as a back-up to the QC Microbiology Product Supervisor Establish and execute the Micro trend analysis programs including utility systems.
• Ensure trend analysis programs including Utility systems and Environmental Monitoring are competed in a timely manner.
• Ensure timely investigation of all environmental monitoring excursions, and testing investigations (and in collaboration with QA, direct the response to excursions which may include additional facility cleaning or area and process reviews)
• Plan and maintain resources (adequate pool of trained personnel) necessary to efficiently execute testing and environmental monitoring.
• Ensure that all Microbiologists are adequately trained to perform duties prior to performing a function, inclusive of management of training records for each technician.
• Establish schedules for EM tests and Personnel Gowning qualification testing including sampling and microbiological organism identification.
• Ensure timely completion of deviations and excursion assessments, batch and utility summary reports, inclusive of quarterly trending.
• Engage with production in microbiological and aseptic operations training and work with quality assurance in directing response actions to objectionable organism recoveries.
• Manage inventories of media and supplies for the QC Microbiology Department based upon forecast planning, expiration dating and stock usage management to ensure adequate supply and minimal waste loss to ensure no delays in production and validation executions.
• In collaboration with Manufacturing, develop and deliver required training programs in microbiology understanding, and aseptic behaviours and aseptic techniques for environmental monitoring technicians and manufacturing personnel.
• Research new technology
• Report Health and Safety incidents, accidents, or potential hazards
• Performs all other related duties as assigned.

In the Laboratory:

• Supervise the accurate and timely completion and approval of Microbiology Laboratory testing and records.
• Review and approve all microbiology test result, validation protocols and reports within assigned timelines.
• Review, initiate and approve, as required, changes to assure continuous improvement of microbiology procedures (test methods, training modules, system SOPs)
• Lead the creation, reviewing, training and implementation of microbiology system SOPs, test methods and training modules.
• Create project plans to meet or establish the microbiology test method transfer/development/validation requirements (timelines/resources) for client manufacturing contracts.
• Establish and justifying acceptance criteria for validation studies.
• Manage and supervise the execution of microbiology method development, transfer, optimization implementation and validation to be consistent with client, production, and regulatory requirements for new products.
• Troubleshoot methods and equipment as required.
• Report, record, and lead investigations for any deviations from company procedures, or other discrepancies that may affect or indicate a microbiological problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long-term corrective action including identifying root causes; facilitate and review final implementation of corrective action plans.
• Ensure that applicable equipment and analytical instruments in the microbiology laboratory are qualified, maintained, and calibrated and that system suitability is properly verified. Review and approve as required Microbiology equipment IQ/OQ/PQ protocols and reports.
• Ensure that all Microbiology staff are adequately trained to perform duties prior to performing tasks or assays.
• Ensure that there is a proper management of the inventory of plates, reagents, and components necessary to execute lab testing and activities.
• Report results to site stakeholders in a timely manner.
• Ensure that the Microbiology laboratory facilities and operations comply with safety and environmental regulations, including chemical and microorganism handling and disposal of laboratory waste.

In support of the EM Program:

• Supervise the accurate and timely completion and approval of environmental monitoring and documentation.
• Plan and supervise the execution of the EM program for all routine batch manufacturing, media fills, performance qualifications and supporting manufacturing areas.
• Review and approve as required all environmental monitoring results, validation protocols and reports within assigned timelines.
• Initiate and implement continuous improvement of microbiology environmental monitoring procedures (test methods, training modules, system SOPs).
• Develop and deliver the training as a part of the implementation of environmental sampling SOPs and test methods inclusive of both written and on the job training
• In collaboration with Validation and Manufacturing develop risk assessments for environmental monitoring locations for both EM Qualification and facility and process performance monitoring based upon facility design, equipment present, personnel, materials and waste flows, and specific process and product risks. These risk assessments will support the PQ protocols for the qualification and re-qualification of new and existing manufacturing areas.
• Review and approve all protocols and reports associated with performance qualifications of the manufacturing area and media simulation studies.
• Troubleshoot methods and equipment as required.
• Record and report according to established procedures any deviations from company procedures, or other discrepancies that may affect or indicate a microbiological problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long-term corrective action including identifying root causes; facilitate and review final implementation of corrective action plans
• Ensure that applicable sampling equipment and analytical instruments in the microbiology laboratory are qualified, maintained and calibrated and that system suitability is properly verified. Review and approve as required Microbiology equipment IQ/OQ/PQ protocols and reports.
• Ensure that the Microbiology laboratory facilities and operations comply with Safety and Environmental regulations, including chemical and microorganism handling and disposal of laboratory waste.

Minimum Qualifications:

• Significant work experience (ideally in a cGMP environment in an Environmental Monitoring or Microbiology field)
• Demonstrated leadership and management skills
• Ability to read, understand, and execute instructions in accordance with SOPs, and other documentation
• Good interpersonal and communication skills, including ability to teach and instruct, and ability to resolve conflict
• Individual must be self-motivated, highly organized and able to work in a fast-paced manufacturing and testing environment

Preferred Qualifications:

• Bachelors degree n Microbiology, Life Sciences
• Strong working knowledge of Global Regulations, various compendia and cGMPs including Annex 1
• Good working knowledge of aseptic techniques and microbial tests
• Strong technical writing and computer skills

Additional Requirements:

• Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as per RESILIENCE SOPs
• This position requires vaccination for Hepatitis A and B
• Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shifts

The items described here are representative of those that must be met successfully to perform the essential functions of this job.Resilience Biotechnologies Inc. (RESILIENCE), 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 to Human Resources.Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $70,000.00 - $107,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidates geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

National Resilience