Production Technician Senior - Vaccine

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

Works with Senior Technicians, leads, and managers to ensure operational area is running as intended to meet all operational goals.

Must attend shift change daily to ensure preparedness for workday.

Completes Real Time SAP transactions on all aspects of Inventory Management.

Obtains and Maintains access to necessary systems as needed (SAP, RT Reports, eDoc, HMI, SCADA access, Virtual Standards, etc.).

Reports production issues and observations and relays to leadership team.

Understands science behind process steps and technology including aseptic processing.

Works to prepare area for oncoming shifts.

Is trained to complete Environmental Monitoring sampling and corresponding documentation.

Works with lead technicians and managers to ensure continuous operation.

Maintains aseptic work environment.

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.

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

Attends Safety Meetings.

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.

Ensures completion of quality documentation (BFR’s, logbooks, etc) accurately in a timely manner.

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

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.

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.

Utilizes 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.

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

Follows proper documentation as required by cGMP.

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

In on time and attends and participates in Shift Change.

Maintains acceptable training as described in key requirements.

All other duties as assigned.REQUIREMENTSEducation/experienceRequires 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 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

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, Utility 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.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.#GD-SP#LI-SPAt 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.