Job Title: Production Technician - Vaccine

Location: Swiftwater, PA

*This is a 2nd shift 2:00 PM - 10:30 PM position

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as a Production Technician - Vaccine within our Filling Team, will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

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.

• Performs production in accordance with volume fluctuation, business need, and effective procedures.
  
• Responsible for Manufacturing actives in assigned area.
  
• Follows all procedures put into effect to ensure your safety as well as the safety of others.
  
• Follows effective procedures to ensure the production of a safe and efficacious product.
  
• Ensures completion of quality documentation (BPR's, logbooks, etc) accurately in a timely manner.
  
• Completes tasks and corresponding documentation as required by cGMP to ensure document completion.
  
• Performs production in accordance with volume fluctuation, business need, and effective procedures.
  
• Responsible for Manufacturing activities in assigned area.
  
• Ensures all materials required for production are available prior to need.
  
• Completes sampling and corresponding documentation as required.
  
• Completes SAP transactions in an accurate and timely manner to ensure accurate inventory.
  
• Participates in all aspects of inventory management (SAP, cycle counting, ordering, etc.).
  
• Identifies all production issues and relays them to the leadership team. Works to prepare assigned areas for the oncoming shifts.
  
• Completes tasks and corresponding documentation as required by cGMP.
  
• Works with Senior/Lead Technicians and Managers to ensure a smooth operation.
  
• Works to become trained in all assigned training modules. Trains new team members (at any level) as assigned.
  
• Follows all procedures put into effect to ensure your safety as well as the safety of others.
  
• Participates in monthly safety meetings.
  
• Report 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.
  
• Works to understand cGMP's.
  
• Identifies areas of deficiency to the leadership team and offers potential suggestions for improvements.
  
• Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product.
  
• Works to complete quality documentation (BPR's, logbooks, etc) accurately in a timely manner.
  
• CFR (code of federal regulations) / PAI inspection readiness.
  
• FDA audit understanding and awareness.
  
• Participates in team meetings.
  
• Actively communicates improvement ideas, issues, concerns, etc to team members.
  
• Participates in cross functional teams where necessary to complete projects in an effective and timely manner.
  
• Inputting data into SAP, along with entering work orders and reagent orders.
  
• Ensures proper process area operation by pre and post run set up and maintenance of lab and equipment.
  
• Recommends changes to BPRs, SOPS and SWIs when warranted.
  
• Write and edit documents under supervision.
  
• Seeks out cross-training in other areas whenever possible.
  
• All other duties assigned.
  

• Is a trained designee to supervise shop floor activities included but not limited to Upstream, Downstream, and BSA responsibilities.
  
• Ensure operational areas are running as intended to meet all operational goals.
  
• Is accountable for the completion of Flu operations including Metasys and Labwatch, corresponding documentation, data entry, etc.
  
• Real time review of process documentation.
  
• Must be able to maintain qualification of area specific training.
  
• Participates or leads in all aspects of production process (SAP, Labware if required, Trackwise, HMI, etc.).
  
• Works to resolve all production issues. Understands next steps and works to guide others through the process to complete them.
  
• Ensures operational areas are staffed adequately, staffed at all times, and manages breaks.
  
• Acts as a liaison for Production, Senior, and Lead Techs to dictate support.
  
• Ensure preparedness for oncoming shifts.
  
• Assists in completion of required BPR updates.
  
• Works with Senior/Lead technicians and managers to ensure continuous operation.
  
• Maintains aseptic work environment.
  

• 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.
  
• Ensures proper training and safety practices are followed in the areas.
  
• Follows effective procedures to ensure the production of a safe and efficacious product.
  
• Utilizes +QDCI boards for Safety issues
  
• Uses HSE Trackwise as needed.
  

• FDA audit understanding and awareness. Ensures process in areas is always following proper procedures
  
• Identifies possible deviation occurrences and prevents or aids in investigations and root cause analysis.
  
• Assist in deviation investigation, CAPA, CCR and project as assigned.
  
• Ensures completion and review of quality documentation (BPR'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.
  
• Uses Phenix to initiate and write deviations and CAPAs as needed.
  

• 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 and real time review.
  
• Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing.
  
• All other duties as assigned. Adheres to all other company time keeping and attendance policies.
  
• Accountable for the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.
  
• Perform post completion review of BPR to ensure accuracy prior to submitting it for review.
  

• Executes procedure as documented to avoid deviations.
  
• Responsibly uses material in an efficient manner to reduce waste.
  
• Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.
  
• Works to resolve all production issues related to area of work.
  

• Works to become trained in all assigned training modules.
  
• Trains and orients new team members (at any level) as assigned. Mentors 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 team where necessary to complete projects in an effective and timely manner.
  
• 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.
  

• 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.
  
• High School Diploma plus one-year experience in a cGMP environment or Pharmaceutical experience
  
• Bachelor's degree with 0-year experience.
  
• Proficiency in at least but not limited to one area of operation or product line.
  
• Works to become trained in all assigned training modules.
  

• 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.
  

• 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)