Cleaning Validation Specialist

Reference No. R2780602

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.Your job, as Manager, Cleaning Validation within our Cleaning validation Team will be to

Manage and coordinate Cleaning Validation activities.

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.

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

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

Maintain the validated status of cleaning processes.

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

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Management (15%)

• Manage and coordinate the Cleaning Development\Validation\Verification\Monitoring activities in B200.

• Train and mentor personnel.

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

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

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

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

Provide Technical Subject Matter Expertise (SME) (70%)

• 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.

• 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.

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

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

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

• Review laboratory logbooks and forms in a timely manner.

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

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

• 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.

• Provide SME support during internal and regulatory audits

Co-operate Transversally (10%)

• 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.

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

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

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

Continuous Process Improvement (5%)

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

• 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

• 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

• 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.

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

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

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

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

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

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

CONTEXT OF THE JOB/MAJOR CHALLENGES

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

• Drive cross-functional alignment.

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

• Participate in continuous improvement in the process industrialization within MTech.

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

• Some travel required in North America and Europe

DIMENSIONS/SCOPE

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

• 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  

• Freedom to act, level of autonomy: interface with function heads; project leaders; experts/SPPs; process & Cleaning validation teams, internal and external testing labs

About You

REQUIREMENTS

Education/Certifications/Experience

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

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

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

• 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).

• Candidate should possess a familiarity with Regulatory Requirements

• Experience in pharmaceutical manufacturing is an asset

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

• Excellent analytical skills, with systematic approaches to problem solving

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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs