Production Technician - Filling

Job description

This will be a 1st, 2nd or 3rd shift position.

Performs production in accordance with volume fluctuation, business need, and effective procedures.  Ensures all materials required for production are available prior to need.  Completes sampling and corresponding documentation as required. Completes move tickets and picklists in an accurate and timely manner to ensure accurate inventory.  Participates in all aspects of inventory management (SAP, cycle counting, ordering, etc.). Identifies all production issues and relays them to the leadership team. Works to prepare assigned areas for the oncoming shifts. Completes tasks and corresponding documentation as required by cGMP.  Works with Senior Technicians and Managers to ensure a smooth operation. May serve as processing room leads and strive to become experts in their assigned areas.

Completes at least one developmental classes annually focused on one of the four core competencies.  Completes at least one developmental class outside of the core competencies annually.  Works to become trained in all assigned training modules.  Trains and orients new team members (at any level) as assigned.

Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings.  Report all safety issues, concerns, incidents and near misses to the team leadership.  Actively participates in safety walkthroughs coordinated by the department’s safety team.  Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

Follows effective procedures to ensure the production of a safe and efficacious product.  Works to understand cGMP’s.  Identifies areas of deficiency to the leadership team and offers potential suggestions for improvements.  Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product. Works with the leadership team to complete deviation investigations and root cause analysis.  Works to complete quality documentation (BPR’s, logbooks, etc) accurately in a timely manner.  CFR (code of federal regulations) / PAI inspection readiness.  FDA audit understanding and awareness.

Participates in team meetings.  Actively communicates improvement ideas, issues, concerns, etc to team members.  Participates in cross functional teams where necessary to complete projects in an effective and timely manner.

Lead Operator, Completes picklists and move tickets for all tasks completed on any given day.  This may require inputting data into SAP, along with entering work orders and reagent orders.  Ensures proper process area operation by pre and post run set up and maintenance of lab and equipment.  Recommends changes to BPRs, SOPS and SWIs were warranted.  Write and edit documents under supervision.  Seeks out cross training in other areas whenever possible.  Responsible for assisting in writing and assisting incident investigations, CAPA's, change controls, along with assisting the higher tech levels and Principle Investigators with projects.

All other duties as assigned.

Basic Requirements:

·  HS diploma or GED and 2+ years manufacturing experience
·  Associates with 1 + year manufacturing experience
·  Bachelors with 0 + years manufacturing experience

Must successfully pass Aseptic Gown training to be considered for this position.

Preferred:

·  Must be able to train and work in multiple production areas in the Filling umbrella including material movement, prep, and the aseptic corridor.
·  Must ensure training and gowning status is acceptable all time to ensure agility to work in aseptic production areas.
·  Must be able to complete training in all areas as required this includes aseptic filling and machine operation.
·  Prior or related cGMP or Pharmaceutical experience recommended
·  Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot.

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.