Production Operator- Vaccines

Role Summary

Production Operator- Vaccines in Swiftwater, PA. Performs production in accordance with volume fluctuation, business need, and effective procedures; responsible for manufacturing activities in assigned area.

Responsibilities

• Follows all procedures to ensure safety for self and others; participates in monthly safety meetings.
• Reports safety issues, incidents and near misses to team leadership.
• Participates in safety walkthroughs and contributes ideas for corrective and preventative actions.
• Follows procedures to ensure production of a safe and efficacious product; utilizes safety boards for issues.
• Attends safety meetings.
• Ensure compliance with quality procedures; maintain quality documentation (BFRs, logbooks) accurately and timely.
• Understands and collaborates with the quality group to maintain positive rapport; monitors for deviations and supports investigations.
• Performs production in accordance with volume fluctuation and business needs; completes tasks and documentation per cGMP; prepares areas for incoming shifts; maintains gowning and dexterity for machine setup; ensures material readiness for aseptic filling; completes Real Time SAP transactions for inventory.
• Performs tasks with attention to safety, quality, and product integrity; adheres to company timekeeping and attendance policies.
• Trains orients new team members; maintains cGMP documentation; supports cross-training in multiple production areas within the Filling umbrella.
• Trains and maintains gowning status; completes training for aseptic filling and machine operation as required.

Qualifications

• HS diploma or equivalent; 3+ years in cGMP or Pharmaceutical experience; or Associates with 2+ years; or Bachelors with 1+ year.
• Good mechanical skills, computer skills, attention to detail; basic mechanical aptitude; troubleshooting and manual dexterity.
• Proficiency in multiple operational areas or product lines; able to train in areas such as BFR review, environmental monitoring, sampling, documentation coordination, logbook review, technical writing.
• Knowledge and access to systems (SAP, Trackwise, Master, EMS, PMS, SCADA, RT Reports, Labware) and buildings/processes with these systems (SFD, PI).

Skills

• Environmental monitoring and aseptic processing understanding
• Documentation coordination and accuracy in cGMP environments
• Team training and cross-functional collaboration

Education

• HS diploma or equivalent; additional degrees or certifications aligned with pharmaceutical manufacturing preferred.