Performs duties associated with the Environmental Monitoring (EM) of batch processing and facilities associated with manufacturing processes in support of a discrete production area such as Filling at Sanofi Pasteur.
Manages EM processes within a team to meet the goals and priorities.
Ensure EM operations are conducted in compliance with SOPs, SWIs, and BFRs.
Ensures EM operations are conducted in compliance with cGMPs, CBER, WHO, EP, and other regulatory bodies.
Plans initiates, and executes the overall EM schedules, coordinating with other EM team members and Manufacturing staff.
Overall responsibilities include routine EM (facilities and batch associated) and personnel monitoring.
KEY ACCOUNTABILITIES OF THIS POSITION INCLUDE:
Facilitates routine and batch associated EM and ensures resolution of issues and escalation as needed to the EM Manager and Manufacturing Manager.
Performs EM tasks in compliance with Sanofi Pasteur procedures, specifications and work instructions, and applicable Regulatory Agencies and completes tasks within the timeframes defined within.
Creates a teamwork environment within the EM team and Manufacturing team in support of management direction and decisions.
Communicates from shift to shift to ensure safety, quality, and efficiency of completion of tasks.
Demonstrate supportive behaviors towards co-workers across shifts within the EM team and Manufacturing team.
Demonstrate behaviors supportive of personal and professional growth of self and co-workers.
Drives improvement at the shop floor level consistent with departmental metrics and KPIs.
Maintains a neat clean and orderly work environment.
Complete all training and qualification requirements assigned.
Support Departmental projects and improvement initiatives within the Level 1 +QDCI.
Always show the utmost commitment to Quality and Safety.
Additional duties or responsibilities may be assigned in addition to this to support the daily operation.
Specific Duties Include:
Viable and Airborne Particulate (Non-Viable) sampling
Real Time alarm acknowledgment and documentation for Airborne Particulate sampling
Setup and End of Process EM for batch processing
Data entry to Business Systems (Master, SAP, MODA, etc)
Grades A, B, C, and D routine EM for facility
Performs Daily building release and performs shift checks in Metasys per procedure
High School Diploma/GED with 6 months in cGMP or Pharma experience
Associates with 3 months+ in cGMP or Pharma experience
Bachelors with 0+ years in cGMP or Pharma experience
Prior or related cGMP or Pharma experience recommended. Degrees in Biological or Health Sciences preferred.
This position may be required to be moved or temporarily flexed to another department or building within the Biologics operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.
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