2nd or 3rd Shift
ABOUT THE ROLE:
Operate general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines.
Requires good documentation skills and attention to detail.
Aseptic gowning in a classified work areas.
Tasks to be completed may include formulation of bulk solutions, aseptic fills of syringes and vials under sterile conditions, filtration, vial and syringe preparation , and component staging.
Operate general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above, critical small or large volume sterile fills.
Operate with minimal supervision complex systems and equipment and optimize their use in accordance with defined goals.
May participate in plant trials for evaluating process modifications.
Troubleshoot processing and equipment problems.
Assist in the implementation of production procedures to optimize manufacturing processes.
May provide training to new personnel in a specific technical process.
Demonstrated ability in the application of requisite skills and applied additional skills and knowledge acquired through experience to perform the more complex tasks of the position.
Generally receive no instructions on routine assignments while under little or no supervision.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Requires physical demands of lifting up to 30 lbs/14 kg to 35 lbs/16 kg.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
May involve work with hazardous materials.
High School Diploma or GED.
Basic Qualifications and/or Preferred Qualifications
3-5 years Pharmaceutical and clean room experience for the aseptic production of sterile products, is preferred; cGMP experience preferred.
Strong content knowledge in CGMP/regulatory compliance.
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.