**Monday-Friday- 8am-5pm with flexibility**
**Looking for individuals with prior exposure/experience to deviation, technical writing, and preventative and corrective action experience**
Job Description Summary Department Description:
The Manufacturing Department is comprised of multiple manufacturing areas which may include Equipment Prep, Small Scale Cell Culture, Media Prep, Large Scale Cell Culture, Buffer Prep, and Capture. The Manufacturing Specialist Organization provides support/direction for all of Manufacturing, including continuous improvement and oversight of all Manufacturing owned interfaces with site Quality Business Systems/Processes.
The Manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing process to manage investigation and improvement initiatives within any of the following: Operations, Upstream, Capture or Downstream.
- Practices safe work habits and adheres to Sanofi's safety procedures and guidelines.
- Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change, to include cross-training with floor personnel to increase technical understanding, to provide quality systems training to floor personnel, and to support a state of general audit/inspection readiness at all times.
- Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
- Organizes and participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Science and Technology.
- Performs training with staff on the floor, as needed.
- Serving as the primary owners/investigators of all Manufacturing deviations, including drafting report, performing interviews, and supporting/facilitating root cause analysis and CAPA development/implementation.
- Serving as primary change owner and risk facilitator for all Manufacturing driven/owned CCRs and providing SME to externally owned CCR when necessary
- Supporting the generation and continuous improvement of all Manufacturing owned SOP and BR by owning and driving document edits through the site DCR process.
- Supporting ownership of calibration and maintenance events for all Manufacturing owned equipment
- Performs work that frequently requires independent decision making and the exercise of independent judgment and discretion.
- Effectively utilizes Microsoft office
Basic qualifications are the minimum requirements that an individual needs to meet the needs to meet the job description. The requirements need to be quantifiable (e.g., two years of project management experience).
- High school diploma/GED or Biotech Certification with 5-7 years of experience in cGXP manufacturing environment, or Bachelor's Degree with 3-5 years of experience.
- Demonstrated knowledge I understanding of biologics manufacturing.
- Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
- Excellent written and oral English Language skills.
Preferred qualifications are additional qualifications or experience that would make an individual ideal for the job. However, if the individual does not have these qualifications, it does not disqualify them from being considered for the job.
- Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering with 5-7 years of experience.
- 2 years of experience with Deviation, DCR, CAPA, or CCR systems
- 1 year of GMP experience in a Quality Assurance/Control role.
- 2 years of hands-on Biologics Manufacturing Experience
- Ability to influence in a cross-functional environment.
- Experience facilitating meetings.
- Experience authoring and reviewing standard operating procedures, on-the -job trainings, and other controlled documents.
- Familiarity with Deviation Management Systems (i.e. Trackwise) and SAP Systems (Athena).
- Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
Special working conditions are specific requirements that an individual needs to perform the job requirements (e.g., 10% international travel; ability to gown and enter clean rooms).
Ability to gown and enter clean rooms.
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.