New
Viral Downstream III
Spectraforce Technologies | |
United States, Pennsylvania, Swiftwater | |
Jul 15, 2026 | |
|
Position Title: Viral Downstream III
Work Location: Swiftwater PA, 18370 Assignment Duration: 12 Months Position Summary: * JOBTI TILE: RMF (Recombinant Manufacturing Facility) (previously BARDA) * This position contributes as a member of a cross-functional team to support the startup of the cGMP manufacturing facility for Flublok /Panblok drug substance in Swiftwater PA and will later continue to support the cGMP commercial manufacturing of drug substances. Key Responsibilities: * Ensuring that processes are always compliant with FDA regulations. * Works to become trained in all assigned training modules. * Identifying and preventing deviations and assisting in investigation and root cause analysis. * Helping with deviation investigations, Corrective and Preventive Actions (CAPA), Change Control Requests (CCR) and other assigned projects. * Ensuring that quality documents like Electronic Batch Records (eBRs) and electronic logbooks are completed accurately and on time. * Ensuring documentation is completed accurately and in real-time is crucial for compliance and quality control. * Preparing areas for the next shift helping to maintain smooth operations and efficiency. * Responsibly use material in an efficient matter to reduce waste. * Sharing improvement ideas, issues, concerns to team members along with providing solutions. * Proactive in identifying and solving production issues to ensure smooth operations. * Follow all procedures put into effect to ensure your safety as well as the safety of others. Participate in monthly safety meetings. * Report all safety issues, concerns, incidents, and near misses to the team leadership promptly. * Actively participate in safety walkthroughs coordinated by the department's safety team. * Provide input on potential safety issues and contribute ideas for the corrective and preventative actions. Qualification & Experience: * High School Diploma plus one-year experience in a cGMP environment or pharmaceutical experience. * Associate Degree and Bachelor's degree with 0-year experience. * 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. * Proficiency in at least but not limited to one area of operation or product line. * Previous cGMP / cGLP, Good Documentation experience. * Previous experience in Aseptic Technique. | |
Jul 15, 2026