Manager, Cleaning Validation

Job description

Reference No. R2725092

Position Title: Manager, Cleaning Validation

Department: Cleaning validation

Location : Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. 

Position Summary:

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Manage and coordinate the Cleaning Validation Team, including technologist(s) and contractor(s).

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Develop strategy, plan, and execute activities related to cleaning process development, cleaning process validation, cleaning process monitoring/verification, cleaning process improvement and implementation for new and existing processes.

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The job is related to compliance, efficacy, quality, and safety.

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Design, plan and execute experiments to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.

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Maintain the validated status of cleaning processes.

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Audit current cleaning processes and ensure compliance with cGMP, site/global quality guidelines and current industry standards.

Key Responsibilities:

Management (15%)

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Manage and coordinate the Cleaning Validation Team, including technologist(s) and contractor(s).

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Train and mentor personnel.

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Ensure compliance to all Sanofi policies/procedures (including HSE), regulatory standards, and validation master plans.

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Coordinate the activities of cleaning development, verification, validation, continuous monitoring, and other relevant activities.

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Ensure protocols, reports and study data are reviewed and approved in a timely manner.

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Ensure that the inventory of consumables and materials required for studies is adequately maintained.

Provide Technical Subject Matter Expertise (SME) (70% with direct report(s) or 85% without a direct report )

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Develop strategy, plan, protocols and execute activities related to cleaning process monitoring/verification in the Toronto site legacy space, B100 and B200 vaccine manufacturing facilities.

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Responsible for the generation of protocols/reports in relation to cleaning validation program or specific projects (e.g., risk assessments, chemical decontamination studies, supportive developmental studies, cleaning validation studies, cleaning verification studies, cleaning monitoring, spray coverage studies, recovery studies, worst case MOC studies, Worst case soil studies, degradation studies, validation master plans), training on protocols and study executions.

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Responsible for scientific and technical aspects of assigned projects and activities.

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Design, plan and execute studies to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.

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Write, review, and execute cleaning related method validation documents.

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Review laboratory logbooks and forms in a timely manner.

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Support developmental projects in relation to new cleaning equipment/processes.

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Support any investigation of non-conformances/deviations encountered during the execution of validations and continuous monitoring/verification activities and generate all necessary reports.

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Write or review/approve technical/quality system documents such as SOPs, Study protocols/Reports, Change Controls, Deviation Investigation Reports, Batch Production Records, as they relate to cleaning validation, cleaning monitoring and regulatory compliance. Provide expert recommendations and training where required.

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Provide SME support during internal and regulatory audits.

Co-operate Transversally (10%)

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Interact with cross functional teams in Production, BRD/ARD, Quality Operations, testing labs and other internal and external groups (local and global) to support process development, process improvement and validation.

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Consult with internal and external testing labs in relation to the testing of samples for cleaning. development/validation/verification/monitoring.

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Participate in relevant project teams, working groups and task forces (local and or global).

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Collaborate with Technical Services and external vendors and ensure adequate maintenance/calibration of the laboratory and the instrument/equipment.  

Continuous Process Improvement (5%)

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Evaluate cleaning SOPs, validation SOPs, and initiate process improvements, as necessary.

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Participate and enhance established Lean Management Systems (including ways of working) for the department and laboratory areas, ensuring continuous improvement in process efficiency. Participate in identifying wastes, safety hazards, and potential improvements.

HSE Requirement/Statement:

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Support and comply with all Sanofi Pasteur Health, Safety and Environmental policies, contribute toward meeting. departmental/platform goals; and demonstrate progress in preventing or reducing injuries and/or illness.

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Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures, and regulations applicable to their work.

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Participates in the investigation of incidents and work-related illnesses.

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Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner.

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Takes every reasonable precaution to ensure the health and safety of staff.

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Ensures that protective equipment and clothing required is used by staff.

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Cooperates and assists the Joint Health and Safety Committee in carrying out its functions.

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Advises staff of any potential or actual health and safety hazard of which they are aware.

Context of the job/Major challenges:

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Office environment: 35 hours a week with occasional visit to the labs and shop floor.

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Drive cross-functional alignment.

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Support the culture of pro-activeness for the management of industrial processes.

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Participate in continuous improvement in the process industrialization within MTech.

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Support the integration of science and risk-based approaches within the framework of lifecycle management of cleaning processes.

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Some travel required in North America and Europe.

Dimensions/Scope:

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Breadth of responsibility (global/regional/country/site):  Toronto, Canada.

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Key dimensions: large biopharmaceutical facility, with extensive scope and complexity in facility/process design and qualification, process improvement implementation; effective cross-functional interaction, communication, and team management. 

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Freedom to act, level of autonomy: interface with function heads; project leaders; experts/SPPs; process validation team of 1+ direct reports.

Key Requirements:

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Bachelor's degree in Sciences or Engineering, with 4+ years of relevant experience; OR

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Master’s degree in Sciences or Engineering, with 3+ years of relevant experience.

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An in-depth knowledge of technical areas specific to cleaning processes is required (Cleaning Process Design & Development, Residues & Limits, Sampling & Markers, Analytical Methods).

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An in-depth knowledge of technical areas specific to manufacturing processes is an asset (e.g Fermentation, Harvest and Purification, Adsorption, Formulation, Scale-up, Cell & Viral Culture, Adjuvants).

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Candidate should possess a familiarity with Regulatory Requirements

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Experience in pharmaceutical manufacturing is an asset

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Sound knowledge of Project Management, Statistical Process Control (SPC) skills and Six Sigma methodology is an asset.

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Excellent analytical skills, with systematic approaches to problem solving

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The position requires additional specific competencies: exp: ability to think strategically, lead teams, develop people, make decisions.

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Act for Change

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Cooperate Transversally

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Commit to Customers

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Strive for Results

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Think Strategically

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Develop People

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Make Decisions

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Lead Teams

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Managing, Organization

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Use of technical and professional expertise

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Impact and Influence

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Balanced judgement

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @SanofiCanada   and on LinkedIn: https://www.linkedin.com/company/sanofi           

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.