Canada-Project Engineer II (Engineering) found on TalentBurst, Inc.
Toronto, ON M2R 3T4
About the Job
Job Title: Project Engineer II/Biosafety Engineer
Location: Toronto, ON, Canada
Duration: 24 Months + Contract
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
o Identification of risk during the appropriate stages of commissioning of the project
o 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;
#LI-FRESH
Location: Toronto, ON, Canada
Duration: 24 Months + Contract
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
o Identification of risk during the appropriate stages of commissioning of the project
o 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;
#LI-FRESH