Regional Environmental Monitoring Expert

• Location: Bogotá

About the job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

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 Regional Qualification Specialist within our M&S Services Bogota Hub, will be acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

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.

Environmental monitoring encompasses the environmental controls of viable and non-viable particles. An EM program evaluates and trends the environmental conditions of qualified cleanroom areas and ensures these are suitable for the related activities by evaluating them against pre-determined requirements linked with the qualified cleanroom grade.

Main responsibilities:

• Address and discuss trends, deviations, and CAPAs during the data collection period
• Conduct initial interpretation and preliminary assessment of results from different data categories
• Include relevant data and graphical elements in reports for enhanced clarity
• Liaise with site-specific SMEs to gain insights and incorporate their expertise
• Document deviations and discuss their potential impact
• Summarize findings, suggesting implications and conclusions
• Write report content using CMS guidelines
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Informing his/her manager of any quality or HSE event (deviations, OOx, etc.) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter
• Bringing, executing and leading ideas to improve processes and “the way of work” of his/her area
• Responsible for working to successfully achieve area KPIs targets
• To keep an excellent working environment
• To be deputy or backup for Sr. Specialist and Specialist
• Support internal and external audits, regulatory inspections, and corporate assessments, ensuring full preparedness and high quality documentation
• Perform comprehensive content and technical reviews to ensure accuracy, completeness, and compliance with guidelines
• Verify accuracy of all data, references, and citations included in reports to ensure regulatory compliance
• Ensure full compliance with GxP principles, regulatory requirements, and the company’s Quality standards throughout Environmental monitoring processes
• Manage Quality Management System (QMS) records, address discrepancies, and ensure timely closure of all related documentation
• Drive continuous improvement initiatives through standardization, simplification, and digitalization of Environmental Monitoring processes

About you

• Experience: Minimum of 5–7 years in GMP environments, ideally with 3+ years specifically in Environmental Monitoring (viable/non-viable particles) or similar areas related to report issuance (e.g., stability management or QV).
• Experience in generating timely and annual EM reports, including:
• Analysis and trending of microbiological data
• Data interpretation
• Identification of adverse patterns and trends
• Soft and technical skills: Attention to Detail: Meticulous and thorough in all tasks.
• Stakeholder Management: Serves as a point of contact with high accountability and strong decision-making capabilities.
• Communication: Ability to convey technical information with clarity.
• Resilience Under Pressure: Capable of handling regulatory pressures effectively.
• Critical Thinking / Root Cause Analysis: Strong analytical skills for identifying and addressing root causes.
• Teamwork and Organization: Collaborative team player with mentoring capabilities.
• Education: Microbiology or related fields
• Pharmaceutical Chemistry or related fields
• Languages: Advanced English level is mandatory.

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• You’ll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
• You’ll be part of a truly diverse cross-cultural team and can have real business impact.
• Flexible working policies, including up to 50% remote work.
• Private medical care, life and health insurance, and gender-neutral paid parental leave
• Colombia is one of Sanofi’s key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
• Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

To apply under the disability condition, it is necessary to have a certificate issued in accordance with the provisions of the Ministry of Health and Social Protection to comply with the obligations established in Law 2466 of 2025 regarding the hiring of people with disabilities.

If you require any reasonable accommodation or adjustment during the recruitment process, please inform the Talent Acquisition team. This information will be treated confidentially and will not impact your application.
 

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

#LI-LAT

#LI-Hybrid

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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