**Monday-Friday- 1st shift position**

8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by upstream, downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.

This Suite Coordinator position is responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations.

The Suite Coordinator will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

CORE RESPONSIBILITIES:

• Create and coordinate training activities and track progress through glidepaths

• Maintain and update training road maps training matrix

• Works with Compliance Specialists to create and close out CAPA’s

• Document Change Requests (DCR’s, EDD’s)

• Participates in cross functional projects and performs SME assessments for CCR’s

• Redundant Manufacturing reviewer of SOP’s, EWI’s, EBR’s and EUR’s

• Performs routine documentation assessments to ensure alignment between SOP’s/EBR’s/EUR’s

• Co-ordinates with MLC’s to ensure adequate stocking of the area

• Partners with supply chain to ensure adequate SUT for operations

• Partners with MFG Supervisor’s to complete audit readiness walkthroughs

• Coordinates with the scheduling team and schedules non-routine activities with support areas

• PMs, Calibrations, action notices

• Works with the scheduling team to report schedule adherence

• Provides input and recommendations on how to accomplish objectives with schedule changes and/or business needs

• Ensures timely issue escalation to manufacturing leadership and cross functional support teams

• Demonstrates flexibility, responsiveness, and teamwork in response to changing schedules and needs of the business

Continuous Improvement

• Contributes to continual improvement of all manufacturing documentation (SOP’s, EWI’s, MBR’s, OJT’s) to ensure they are current, accurate, and clear

• Manages or supports plant floor continuous improvement initiatives

• Represents Manufacturing in Project Team meetings; may lead department initiatives and projects

LEADERSHIP QUALIFICATION:

• Able to work with and lead cross functional teams through complicated processes in a Quality system

• Capable of effective and clear communication that enables teams to execute on key deliverables

BASIC QUALIFICATIONS:

• Bachelor’s degree with greater than 5-8 years of cGMP experience

• Strong understanding of cGMP manufacturing

• Demonstrated ability to effectively coach and train employees

PREFERRED QUALIFICATIONS:

• Training, coaching, leadership experience

• Experienced facilitating meetings

• Experienced reviewing electronic batch records, electronic work instructions, on-the-job-trainings, and other controlled documents

• Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment

Special Working Condition:

• Ability to lift up to 50 lbs

• Ability to stand on average 6 hours per shift

• Ability to gown and gain entry to manufacturing areas

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.

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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.