Production Technician - Vaccine

Job Title: Production Technician - Vaccine

Shift Schedule:  4 day - 10 hour shifts, Friday through Monday

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

Performs production in accordance with volume fluctuation, business need, and effective procedures.  Responsible for Manufacturing actives in assigned area.  Performs production in accordance with volume fluctuation, business need, and effective procedures.  COVID vaccination required

KEY ACCOUNTABILITIES

• Batch record review

• Sampling palletizing labeling segregation

• Sample delivery to QC and Canada

• Reconciliation

• Line Clearance

• Visual inspection of product (Bench)

• Operation and troubleshooting of visual inspection machines

CONTEXT OF THE JOB/MAJOR CHALLENGES

• Understands visual inspection is our critical task along with operating and troubleshooting our visual inspection machines. 

• Understands the importance of visual inspection and proper sampling palletizing, labeling and segregation of product. 

• Understands proper location of rejects to ensure they are placed in the correct location. 

• Must be able to work in a dynamic setting where personnel are relocated based on business need.

• Understands upstream and downstream processes and how they affect the department.

DIMENSIONS/SCOPE

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

Their responsibilities are, but are not limited to:

Safety:

• Participates in monthly safety meetings.

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

• Understands how to work the SOR system. 

• Works with the safety and leadership team to provide input for potential safety issues as well as contributing ideas, implement all safety initiatives by actively and effectively communicating the initiatives and by helping others to understand the initiatives.

• Works with the safety team to ensure that the resources required addressing safety issues are secured in a timely manner and that the effective resolutions are put into place and trained upon. 

Quality:

• FDA audit understanding and awareness.  Ensures process in areas is following proper procedures at all times

• Identifies possible deviation occurrences and prevents or aids in investigations.

• Participate in completing at least one incident investigations.

• Ensures completion and review of quality documentation (BIR’s, logbooks, etc) accurately in a timely manner for process area assigned.

• Understands the function of the quality group.

• Writes edits and reviews process documentation for completeness. 

• Identifies areas of deficiency and offers suggestions for improvements. 

Delivery:

• Bench lead, cap check, stopper check, zone 1 and zone 2 tech and relief.

• Participates in delivery and reconciliation with QC

• Ensures the completion of sampling and corresponding documentation as required.

  • Sample delivery on site.

• Ensures the completion of move tickets to ensure accurate inventory. 

Cost:

• Participates in all aspects of production process and access required for these processes.  Some examples:

  • SAP Goods Receipt

  • SAP Bin to Bin

  • SAP Reversals

  • LIMs Labware (WARP)

  • Trackwise Deviation

  • Trackwise HSE

  • eBuy

  • eDoc

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

• Continuous monitoring of reject rates.

• Hour by hour update

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

Involvement:

• Works to become trained in all assigned training modules.

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

• Participates in team meetings.  Understands respect, professionalism, and confidentiality.

• Ensures all materials required for production are available prior to need. 

• Follows proper documentation as required by cGMP.

• Has a thorough working knowledge of cGMP’s and works to help others understand. 

• Involved in at least one cross functional teams where necessary to complete projects in an effective and timely manner.

  • Seeks out cross training in other areas within the department and completes at least 1 process training in new area whenever possible. 

  • Continues development by completing at least one developmental class annually. 

• Is a processing room lead and strive to become an expert in their assigned area. 

  • Pre and post run set up.

  • Weight cheek operator

  • Seidenader operator

  • Bosch operator

  • Bench lead

  • Stopper check operator

  • Cap check operator

  • Participates in lidding

• Maintains qualified trainer status if applicable.

All other duties as assigned.

This position is scheduled for a 4-day, 10 hours day work week. The schedule is Friday to Monday with Tuesday to Thursday being nonscheduled days.

REQUIREMENTS:

EDUCATION/EXPERIENCE

• Requires good mechanical skills, computer skills and is detail oriented. Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.

• Prior or related cGMP or Pharmaceutical experience recommended

• HS diploma or equivalent and 2+ years in cGMP or Pharmaceutical experience

• Associates or equivalent with 1 + years in cGMP or Pharmaceutical experience

• Bachelor’s in sciences or equivalent or Pharmaceutical experience

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

• Potential to be a qualified trainer in one or more areas.

• Must have knowledge and access to systems in applicable buildings and processes.

THE FINE PRINT 

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

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

• 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.

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

• 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.