Prod Tech Sr - Vaccine

This is a 3rd shift position.

Ensure operational area is running as intended to meet all operational goals.  

Ensures the completion of Environmental Monitoring sampling and corresponding documentation, data entry, and delivery as required during all aseptic processing. Real time review of this documentation.

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:

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

• Reports 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.

• Utilizes +QDCI boards for Safety issues

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 and root cause analysis. 

• Participate in completing at least one incident investigations, one CAPA action item, or one change control action item, along with projects.

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

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

• Writes edits and reviews process documentation for completeness. 

• Identifies areas of deficiency and offers suggestions for improvements. 

• Maintains acceptable execution with no emerging negative trends in procedural deviations

Delivery:

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

•  Completes tasks and corresponding documentation as required by cGMP to ensure document completion.

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

• Ensure proper septic set up and installation of aseptic fill parts and Filler set up. This is done in a Grade A environment. Must ensure maintenance of gowning and Physical dexterity to complete proper set up of machines so not to impact the safety, quality, and integrity of the product.

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

•  Ensures all Final Container materials required for production are available prior to need. These materials must be ready for aseptic filling operations to ensure the safety, quality, purity, and integrity of the product is maintained.

•  Ensures the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.

Cost:

• Executes procedure as documented to avoid deviations.

• Responsibly uses material in an efficient manner to reduce waste.

• Utilized Filling Standards to capture and Record HRxHR and Change Over Activities.

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

• 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.  Mentors Associate and Production techs.

• Participates and leads 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. 

• Ensures all areas within the department are adequately covered at all time for current shift and upcoming shifts.

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

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

• Training coordinator / Trainer –Train and guide Personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

All other duties as assigned.

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

• Participates or leads in all aspects of production process (SAP, Labware if required, Trackwise,  RT Reports , eDoc, HMI, SCADA access, Virtual Standards, etc.).

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

•  Understands science behind process steps and technology including aseptic processing. This including working knowledge of complex automation system used in Filling as well as Operator access to these systems ( SCADA, INOVA FILLER, Depy Tunnel, EMS, PMS, etc).

•  Ensures operational area is adequately staffed at all times.

•   May serve as Preparation or Aseptic room leads and strive to become experts in their assigned areas

• Assists in completion of required BFR updates. 

• Works with lead technicians and managers to ensure continuous operation.

• Maintains aseptic work environment.

Requirements:

• HS diploma or equiv and 3+ years in cGMP or Pharmaceutical experience

• Associates with 2 + yrs in cGMP or Pharmaceutical experience

• Bachelors with 1 + yrs in cGMP or Pharmaceutical 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

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

• Must be a qualified trainer in one or more areas. Must be proficient in at least one of the following areas: BFR review, Environmental monitoring, Utliliy Sampling,  Documentation Coordinator, logbook review, technical writing (SWI revisions).  

• Must have knowledge and access to systems (SAP, Trackwise, Master , EMS, PMS, SCADA, RT Reports, Labware).

• Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI)

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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.