Production Operator- Vaccines

Role Summary

Production Operator- Vaccines. Location: Swiftwater, PA. Join a global network in Manufacturing & Supply to help deliver life-changing treatments faster. Performs production in accordance with volume fluctuation, business need, and effective procedures; responsible for manufacturing activities in the 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; actively participates in safety walkthroughs.
• Provides input for potential safety issues and contributes ideas for corrective and preventative actions.
• Follows procedures to ensure the production of a safe and efficacious product; uses +QDCI boards for safety issues; attends safety meetings.
• Ensures process compliance with FDA/Audit requirements; supports deviation investigations and root cause analysis.
• Completes quality documentation (BFRs, logbooks, etc.) accurately and timely; maintains positive rapport with quality group.
• Maintains acceptable execution with no emerging negative trends in procedural deviations.
• Performs production in accordance with volume fluctuation and business needs; flexible to staffing changes; completes required cGMP documentation.
• Prepares assigned areas for oncoming shifts to ensure continuous operation; maintains gowning and dexterity for proper machine setup.
• Ensures availability of Final Container materials for aseptic filling; completes Real Time SAP transactions accurately for inventory.
• Executes procedures to avoid deviations; uses materials efficiently; records HRxHR and change-over activities; communicates improvement ideas and solutions.
• Trains and orients new team members; follows cGMP documentation; understands and assists others with cGMP requirements.
• Attends shift changes on time; maintains training as required; performs duties across multiple production areas within the Filling umbrella as needed.
• Maintains an aseptic work environment; trains in Environmental Monitoring and related documentation; ensures training and gowning status are current.
• Works with leads and managers to ensure continuous operation; prepares area for oncoming shifts; completes training across required areas.
• Supports ongoing area readiness and environmental monitoring documentation; ensures readiness for aseptic production.
• Maintains access to systems required for inventory and production operations (e.g., SAP, RT Reports, eDoc, HMI, SCADA, etc.).

Qualifications

• Requires good mechanical skills, computer skills, and attention to detail; basic mechanical aptitude, troubleshooting, and manual dexterity.
• Prior or related cGMP or Pharmaceutical experience recommended.
• Proficiency in at least three areas of operations or product line.
• Must be a qualified trainer in one or more areas; proficient in areas such as BFR review, Environmental monitoring, Utility Sampling, Documentation Coordinator, logbook review, or technical writing (SWI revisions).
• Must have knowledge and access to systems (SAP, Trackwise, Master, EMS, PMS, SCADA, RT Reports, Labware) and familiarity with SFD/PI environments.

Education

• HS diploma or equivalent and 3+ years in cGMP or Pharmaceutical experience
• Associates with 2+ years in cGMP or Pharmaceutical experience
• Bachelors with 1+ year in cGMP or Pharmaceutical experience