Senior EM Technician - 1st Shift
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This is a 1st shift position
Performs duties associated with the Environmental Monitoring (EM) of product 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. Assures that EM operations are conducted in compliance with SOPs, SWIs and BFRs. Responsible for the EM of bacterial and/or viral products to meet established requirements. Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Plans, initiates and executes the overall EM sampling schedules, coordinating personnel activities with other EM and Manufacturing staff. Overall responsibilities include EM monitoring (facilities and batch associated), ESUM package compilation and documentation, gown plating and training among others.
Key accountabilities of this position include:
Facilitates EM workflow in the production floor to ensure satisfactory resolution of issues and escalates as required to the area Manager and EM Manager.
To ensure that product(s) is manufactured in conformance with regulatory agency standards through review of procedures, and assuring availability and maintenance of appropriate equipment, materials, and facilities.
Performs EM tasks in compliance with Sanofi Pasteur SOPs and applicable Regulatory Agencies.
Generates work orders for EM equipment in the SAP system and interacts with support functions like Sterility Assurance and IS.
Initiates and performs assessments for deviations within Trackwise / Phenix in a timely manner.
Creates a team work environment for the staff in support of management direction and decisions.
Communicates line status and EM requirements from shift to shift to assure all safety, quality and efficiency objectives are achieved.
Demonstrate supportive behaviors towards co-workers across shifts, departments and job levels.
Demonstrate behaviors supportive of personal and professional growth of self and co-workers.
Actively participates in the training and coaching of new employees in the areas of environmental monitoring, gowning, aseptic techniques,daily release.
Performs EM operations according to department procedures, specifications or work instructions and completes tasks within instructions-defined time frames.
Support project teams and represents the Filling department as required with an emphasis on EM.
Drives improvement at the shop floor level consisten 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.
Leads by example in the shop floor by executing activities and coaching technicans on the proper SOPs and practices.
Show the outmost commitment to Quality and Safety at all times.
Additional duties or responsibilities may be assigned in addition to this to support the daily operation.
Specific duties include:
EM Operational Expert (SME)
Viable and Non-Viable sampling
Real Time alarm acknowledge and documentation for Non- Viable / Airborne Particulate sampling
Pre and Post lot EM sampling
Data entry to Business Systems (Master, Pharmweb, SAP,etc)
ESUM Initiation and submission to sterility Assurance
Grade A, B, C, D and utilities routine EM
EM supply and equipment management (plate inventory and Lasairs calibrations, etc)
Initiate Daily release
Review of EM logbooks
Initiating and assessing deviations
High School Diploma/GED with 5 years in cGMP or Pharma experience
Associates with 4+ years in cGMP or Pharma experience
Bachelors 2+ years in cGMP or Pharma experience
Prior or related cGMP or Pharma experience recommended. Degrees in Biological or Health Sciences preferred.
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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