The incumbent will supervise the Microbiology Environmental Monitoring Technicians and ensure that all sampling and documentation is conducted in compliance with cGMP regulations, company policies, safety standards and departmental procedures and standards. They will plan and supervise the execution of the environmental monitoring program for all routine batch manufacturing, media fills, performance qualifications and supporting manufacturing areas. The EM Supervisor will assist in planning to maintain adequate resources (adequate pool of trained environmental monitoring personnel, equipment and materials) necessary to efficiently execute the Environmental Monitoring Program at TBI. They will also ensure timely completion of deviations and excursion assessments, batch and utility summary reports, inclusive of quarterly trending. The incumbent will also engage with production in microbiological and aseptic operations training and work with quality assurance in directing response actions to objectionable organism recoveries.
- Supervise the accurate and timely completion and approval of environmental monitoring and documentation.
- Maintain Micro trend analysis programs including Utility systems and Environmental Monitoring.
- 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 timely investigation of all environmental monitoring excursions, and in collaboration with QA direct the response to excursions which may include additional facility cleaning or area and process reviews
- 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 all Environmental Monitoring Technicians are adequately trained to perform duties prior to performing a function, inclusive of management of training records for each technician
- Establish schedules for Environmental Monitoring tests and Personnel Gowning qualification testing including sampling and microbiological organism identification.
- Manage environmental monitoring plate inventories 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.
- Ensure that the Microbiology laboratory facilities and operations comply with Safety and Environmental regulations, including chemical and microorganism handling and disposal of laboratory waste.
- Act as a back-up to the QC Microbiology Product Supervisor.
- Assist in establishing costs for environmental and personnel monitoring sampling.
- In collaboration with Manufacturing, develop and delivering 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.
- Bachelor’s degree in Microbiology, Life Science, Chemistry/Biochemistry or Microbiology college diploma/certification together with 5-10 years related work experience.
- Demonstrated leadership and management skills.
- Strong working knowledge of Global Regulations, various compendia and cGMPs including Annex
- Demonstrated leadership skills
- Good working knowledge of aseptic techniques and microbial tests
- Strong technical writing and computer skills
- Good interpersonal and communication skills, including ability to teach and instruct
- Individual must be self-motivated, highly organized and able to work in a fast-paced manufacturing and testing environment
- Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s 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
While we appreciate your 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 checks (for which a pardon has not been granted).
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 to Human ResourcesApply Now