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Job Title: Production Technician - VaccineLocation: Swiftwater, PAAbout the JobThis will be a 2nd shift position.This is a B77 Filling.Performs 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, Gibralter, 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. Works with Senior technicians, 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, LYO and Isolator. Must be able to complete training in all areas as required. This role is for a nonexempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.Key Accountabilities:
Performs 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, Gibralter, 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.
Works with Senior technicians, 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, LYO and Isolator.
Must be able to complete training in all areas as required.
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 areas are 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 real time filling data and Change Over Activities.
Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.
Involvement:
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.About youBasic Qualifications
High School diploma or GED with 1+ years prior manufacturing work experience
Associate degree with less than 1-year prior manufacturing work experience
Preferred Qualifications
BS degree and any prior manufacturing work experience
Prior experience in the Swiftwater Biologics and/or FFIP departments or other good manufacturing practices (GMP) facilities
Experiences with Lyophilization and Isolators is preferred.
Knowledge and access to SAP, Trackwise, Master, EMS, PMS, SCADA, RT Reports, and Labware is preferred
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.#GD-SP#LI-SP#LI-Onsite