Sample Manager, Cleaning Validation

Reference No. R2780597 

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 Sample Manager, Cleaning Validation within our Cleaning validation team will be to Manage and coordinate the Cleaning Validation sampling activities, including sample estimation, delivery, sample tracking, sample documentations, testing confirmation, result availability and overall sample reconciliation.

Develop strategy, plan, and execute activities related to sample management of cleaning process development, cleaning process validation, cleaning process monitoring/verification and cleaning process improvement.

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

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 (55%)

• Manage and coordinate the Cleaning Validation\Verification\Monitoring sample management activities.

• Train and mentor personnel.

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

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

• Ensure that sample requests are created, sampling labels created, samples delivered and tested in a timely manner.

• Functions as the point of contact between the testing labs and the cleaning validation/verification/monitoring project stakeholders

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

Provide Technical Support (10%)

• Support any investigation of non-conformances/deviations encountered during the execution of cleaning validations/continuous monitoring/verification activities.

• 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.

Co-operate Transversally (30%)

• Interact with cross functional teams in Production, Quality Operations, testing labs and other internal and external groups 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.  

Continuous Process Improvement (3-5 %)

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

• Participate and enhance established ways of working on the management of cleaning validation/verification/monitoring samples, ensuring continuous improvement and process efficiency.

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 MSAT.

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 validation teams, internal and external testing labs

About You

REQUIREMENTS

Education/Certifications/Experience

• Bachelor’s or master’s degree in sciences or engineering, with 1+ years of relevant experience in pharmaceutical manufacturing, sample management, and project management/co-ordination.

• Knowledge of technical areas specific to cleaning processes (Cleaning Process Design & Development, Residues & Limits, Sampling & Markers, Analytical Methods) is considered an asset.

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

• Sound knowledge of Project Management including project co-ordination, stakeholder management and excellent communication skills.

• Proficiency with Microsoft excel and/or programming is an asset.

• Excellent analytical skills, with systematic approaches to problem solving and high level of proactiveness is required.

• The position requires additional specific competencies: exp: ability to think strategically, lead teams, and 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