This will be a 1st, 2nd, or 3rd 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.
Their responsibilities are, but are not limited to:
· 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.
· 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
· 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.
· 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.
· 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.
· High School diploma or GED with 1+ years prior manufacturing work experience
· Associates degree with less than 1-year prior manufacturing work experience
· 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 prefered
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.
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.