Senior Production and Sampling Technician- Manufacturing

Job description

**Gowning up to 8 hours per day- 4 days per week**

**Gowning/Aseptic Technique Experience**

**Glassware Parts-Equipment Automated & Hand Washing / Autoclave Load & Operation/ Build Manufacturing Transfer Assemblies / Environmental Monitoring, Water for Injection & Clean Steam Sampling / Record/Document Processes & Tasks Performed'

**Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs**

The Facilities Associate candidate will primarily support the Manufacturing organization as part of the Glassware Prep, Autoclave & Environmental Sampling support team.

Activities require the adherence to all documented SOPs, cGMP & Aseptic technique used by the team. 

Responsibilities include washing, drying, assembling & sterilizing  components needed to manufacture product at the Pearl River facility ensuring optimal sanitation for components to be readily available by the Manufacturing team. Environmental Sampling/Monitoring is also part of the responsibility of this role.

In addition to regular duties, the Facilities Associate will perform organization of glassware components to ensure efficient accessibility, cleaning of equipment, equipment surfaces & documentation as part of the daily routine.  

The role also supports stocking material as needed for glassware prep assemblies & maintain & stocking of gowning items within the airlocks throughout the manufacturing facility.

In being proactive, the Associate contributes to providing an efficient work environment to minimize disruption to the production schedule.  Provides technical assessments to the Manufacturing Manager/Director to recommend appropriate action(s) to address issues in production material supply, maintenance, EM, WFI & Steam sampling support for our GMP environment. The candidate will ensure any facility or equipment concerns are reported to management to ensure they meet GMP guidelines. The Facilities Associate must be focused on being Inspection Ready. 

 

Key Accountability

·  Thorough understanding of techniques and processes being executed daily, per documented SOPs, cGMP & Aseptic technique.
·  Clear understanding of cell culture, manufacturing & EM scheduling & the support required by working closely with all team members routinely.
·  Ability to present and explain techniques and results of manufacturing processes with outside departmental personnel.
·  Cleaning and sterilization of critical components to support Manufacturing operations including the operation of mechanical cleaning systems, dryer & autoclave.
·  Assembly of complex transfer assemblies to support Manufacturing operations.
·  Manage sterilized equipment inventory by being familiar with the needs of operations staff and the production schedule.
·  Perform/Support the required Environmental, WFI & Steam Sampling/Monitoring.
·  Documentation to support the functions of the Glassware Prep, Autoclave & Environmental Monitoring, Water & Clean Steam Sampling procedures.
·  Review of documentation & signoff is required for Autoclaving & EM sampling.
·  Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
·  Replenish Glassware & Airlock Gowning Material as needed.
·  Assist with the monitoring of the Glassware & EM inventories as well as gowning supplies & alert Logistics management of inventory requirements in a proactive manner.
·  Operation and triage of utilities equipment during off hours as qualified and directed.
·  Other duties as they are required.
· 

Education/experience

·  High School degree with 5 years -Pharma/Biotech Manufacturing Support and 3 years- Clean Room
·  Experience specifically in Pharma/Biotech Manufacturing Support a PLUS
·  Clean Room Manufacturing experience desirable
·  Environmental Monitoring, Water & Steam sampling
·  Knowledge of cGMP
·  Fluent in English both written and spoken
·  Good communication skills
·  Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed

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.