Aseptic Production Technician - Vaccine

Job description

Aseptic Production Technician (2nd Shift) - Vaccine

**Shift Schedule: 2nd Shift** 2pm-10pm

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

Responsible for working inside the fill area.  Performs production in accordance with volume fluctuation, business need, and effective procedures.

KEY ACCOUNTABILITIES

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Performs production in accordance with volume fluctuation, business need, and maintains aseptic qualifications. Maintains training for and completes closed system connections and sampling requirements.

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Completes testing of process related filters.

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Ensures all required water samples are performed.

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Performs routine inventories and escalates missing equipment/materials to senior or management.

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Consults senior aseptic technician or manager on a routine basis and ensures all parts and materials are available.

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Ensures segregation of components.

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Understands changeover steps for process.

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Signed off on Grade B RABS Environmental Monitoring.

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Qualified to execute Grade B RABS and C/D cleanings.

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Trainer in debag or vial wash, cleaning, and SAP - 70%

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Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc).

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Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all materials.

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In on time and attends and participates in Shift Change - 10%

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Completes all required training - 10%

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Development items – training outside of area of focus - 10%

CONTEXT OF THE JOB/MAJOR CHALLENGES

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Ensures process in areas is always following proper procedures.

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Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all materials.

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Performs routine audits of areas.

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Executes procedure as documented to avoid deviations.

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Responsibly uses material in an efficient manner to reduce waste.

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Utilize Operating Management System (OMS) tools in place to ensure efficient processing.

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Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.

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Works to resolve common production issues related to area of work.

POSITION OVERVIEW

Summary of purpose/major responsibilities

Responsible for working inside the fill area. Performs production in accordance with volume fluctuation, business need, and effective procedures.

KEY ACCOUNTABILITIES

· 
Must be flexible to ensure staffing for production needs and maintain aseptic qualifications.

· 
Maintains training for and completes closed system connections and sampling requirements.

· 
Fully trained to perform non-routine and routine interventions

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Escalates issue to the Lead Aseptic Technician and Managers

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Coordinates movement of bulk product with managers. 

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Completes testing of process related filters. 

· 
Performs routine inventories and escalates missing equipment/materials to senior or management. 

· 
Consults schedule on a routine basis and ensure all parts and materials are available.   

· 
Ensures segregation of components. 

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Maintains aseptic gowning.

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Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc). Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.

· 
In on time and attends and participates in Shift Change.

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Must be able to be complete and maintain qualification of utility sampling of WFI, Clean Steam, and DI as required to keep building GMP.

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Participates in production process (SAP, Labware if required, Trackwise, RT Reports, eDoc, HMI, SCADA access, Virtual Standards, etc.).

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Works to resolve all production issues.  Understands next steps and works to guide others through the process to complete them.

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Works with senior technician and managers to ensure continuous operation.

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Assists with identification and closure of area irritants.

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Use and completion of OMS tools

Or

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Must be flexible to ensure staffing for changing business volume and needs.

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Maintains training for and completes Grade B EM, cleaning, and SAP

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Performs routine inventories and escalates missing equipment/materials to management. 

· 
Consults schedule and ensures appropriate cleanings are completed.   

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Training of all new technicians. 

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Ensures segregation of components.

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Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs. Must ensure maintenance of gowning and Physical dexterity.

· 
Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc). Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.

· 
In on time and attends and participates in Shift Change.

· 
Works to resolve all production issues.  Understands next steps and works to guide others through the process to complete them.

· 
Ensures operational area is always adequately staffed.

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Strive to become experts in their assigned areas

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Works with lead/senior technicians and managers to ensure continuous operation.

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Assists with identification and closure of area irritants.

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Use and completion of OMS tools

This role is for a nonexempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time. 

Their responsibilities are, but are not limited to:

Safety:

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Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings.

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Reports all safety issues, concerns, incidents and near misses to the team leadership.

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Actively participates in safety walkthroughs coordinated by the department’s safety team.

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Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

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Follows effective procedures to ensure the production of a safe and efficacious product.

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Utilizes +QDCI boards for Safety issues

Quality:

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Regulatory audit understanding and awareness.

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Completes Shop Floor Gemba walks.

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Ensures document revisions, logbooks, and forms are maintained as the correct revision on the production floor.

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Understands the function of the quality group and works with them to maintain a positive rapport.

Delivery:

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Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.

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Completes all assigned training

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All other duties as assigned. Adheres to all other company time keeping and attendance policies.

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Ensures proper Aseptic technique is followed

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Completes all SAP transaction is completed in real time

Cost :

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Executes procedure as documented to avoid deviations.

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Utilizes OMS appropriately

· 
Works to resolve common production issues

Involvement:

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Works to become trained in all assigned training modules. Attends the daily shift change.

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Trains and orients new team members (at any level) as assigned. 

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Participates and leads team meetings.  Understands respect, professionalism and confidentiality.

Requirements

Education/experience

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Requires good mechanical skills, computer skills and is detail oriented.

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Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.

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Prior or related cGMP or Pharmaceutical experience recommended

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HS diploma or equivalent and 1+ years in cGMP or Pharmaceutical experience

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Associate’s with 6+ months in cGMP or Pharmaceutical experience

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Bachelor’s degree

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Proficiency in at least but not limited to three areas of operations or product line.

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Must be proficient in at least one of the following areas: Utility Sampling, equipment prep, tank movement OR Must be a qualified trainer in vial wash or debag and SAP

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Must have knowledge and access to systems (SAP, Master, SCADA, RT Reports, Labware) OR Must have knowledge and access to systems (SAP, HMI).

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All other duties as assigned.

THE FINE PRINT 

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For influenza production roles (excluding FFIP roles) : candidate must be able to be receive influenza vaccine which is required for building access

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For aseptic area production roles ( excluding Flu production tech roles) : candidate must be able to obtain and maintain current aseptic gowning qualification

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This position may be required to be moved or temporarily flexed to another department or building within the FFIP operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.

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Must be able to lift up to 25 lbs., and bend/lift/move objects as part of the job.

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Able to stand for up to 8 hours a day (with occasional breaks)

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.