North York, Ontario
Biosafety Officer Assistant
Permanent full-time, North York
Leading pharmaceutical group
Support the Site’s Health, Safety and Environment (HSE) program in applying HSE by design principles. Under the direction of the Biosafety Officer, the assistant biosafety officer will coordinate and help to develop the biosafety, biocontainment, and biosecurity program for a new Containment Level 3 facility at the Sanofi Toronto site.
Biosafety Compliance and Commissioning (80%):
- Assist the BSO with creating a CL3 program, including training, SOPs, medical surveillance, HPTR licensing
- Assist the BSO with creating, updating and revising SOPs to incorporate precautions, instructions, and critical controls as related to the PPD project.
- Support project team(s) by being the primary point of contact for biosafety maters related to CL3 laboratory and production suite;
- Conduct CL3 and biosafety related training
- Support with conducting biological risk assessments for new processes.
- Assist the BSO with conducting biosafety inspections.
- Assist with administration of the biosafety program and other HSE department programs.
- Assist on resolving biosafety and biocontainment issues in laboratories/manufacturing areas where biological materials are used.
- Assist the BSO with investigations of accidents/incidents/exposures.
- Assist the BSO in the development of HSE procedures related to biological materials and biohazardous waste disposal.
- Coordinate the management of related CAPAs in Trackwise
- Other duties as assigned by the BSO
Other Duties as Assigned (20%)
- Ensure regulatory requirements (eg. Canadian Biosafety Standards, Occupational Health & Safety Act, Industrial Regulations, Construction Projects, etc.) for the strategy and execution are met.
- Act in a timely fashion to address and/or escalate significant high-risk items that require immediate attention.
- Assist design team in applying safe and sustainable HSE/Biosafety solutions for identified risks.
- Conduct and develop HSE training and procedures as required.
- Communicate to site HSE for regular updates on project status.
Breadth of responsibility (global/regional/country/site):
- Toronto site – Building 53, Mobile laboratory
Key dimensions: headcount (direct and indirect) budget, doses, Capex… – Key indicators on which the job holder will be evaluated (WHAT in 9box):
- Conformance to HSE Project Requirements with
- Identification of risk during the appropriate stages of commissioning of the project
- Mitigation of identified risk using ALARP principles
- On schedule execution of HSE assessments, communication of results, escalation of issues as required
- Works in partnership with the project team, external consultants and the general contractor
Freedom to act, level of autonomy:
- Reports directly to the Deputy Director Biosafety
- Consult HSE subject matter experts where appropriate (Biosafety, Environment & Sustainability and Safety & Hygiene)
Specific degree, duration of experience (Required to hold the job):
- Minimum Bachelors’ degree in biological sciences, microbiology, molecular biology, public health or a related degree
- Minimum 3-5 years work related experience and knowledge of HSE regulations/standards/codes, including knowledge of the PHAC Canadian Biosafety Standards, HPTA/HPTR.
- Biosafety principles and biocontainment knowledge is required.
- Data management including spreadsheets and databases is required.
- Previous Work on biosafety commissioning projects is an asset.
- Registered Biosafety Professional (RBP) designation, or equivalent, is an asset.
- Previous pharmaceutical manufacturing experience is an asset.
- Knowledge of scientific procedures, laboratory practices and equipment is an asset.
- Experience with high-containment laboratories and facilities (e.g., CL3) is an asset.
Competencies (LEAD model) – key competencies the job holder will be evaluated on (HOW in 9box):
- Act for Change, Cooperate Transversally, and Develop People.
Key technical competencies and soft skills:
- Knowledge of biosafety hazards and hierarchy of controls;
- Knowledge of PHAC HPTR and HPTA, Canadian Biosafety Standard;
- Knowledge of general biosafety safety principles;
- Knowledge of mechanical systems (HVAC systems, power generation, utilities) is an asset;
- Ability to work transversally across functions;
- Ability to make risk based decisions;
- Ability to influence;
- Ability to plan, coordinate and schedule;
- Strong problem solving and people skills;
- Excellent communication skills (verbal, written and presentation);