New 
Viral Downstream III (1st Shift)
 Spectraforce Technologies | |
 United States, Pennsylvania, Swiftwater | |
 Nov 12, 2026 | |
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Position Title: Viral Downstream III
Work Location: Swiftwater, PA 18370 Assignment Duration: 12 Months Work Schedule: 1st Shift 6 AM to 2:30 PM Work Arrangement: Onsite (production floor in plant uniform) Position Summary: * Large scale manufacturing environment. Work is on production floor in plant uniform (blues). * Positions will likely begin in Equip Prep, Logistics Areas as these require less training lead time - materials movements, wipe downs, autoclave, parts washers, potentially environmental monitoring with potential to move into more complex areas based on previous experience, aptitude, and performance. Background & Context: 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 * 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. * Associate Degree and Bachelor's degree with 0-year experience. * Previous cGMP / cGLP, Good Documentation experience * Previous experience in Aseptic Technique * Proficiency in at least but not limited to one area of operation or product line. * Integrity, Flexibility, Adaptability, Willingness and Ability to learn, Positive AttitudeSpecial Working Conditions: * Ability to lift up to 50 lbs. * Ability to stand on average 8 hours per shift. * Ability to gown and gain entry to manufacturing areas. * Ability to be flexible with work schedule. Potentially modified shifts for training and business needs including holidays and weekend * May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need. * May also include working in an aseptic processing area. * Fit testing requirements of N95 may be required depending on the area you are assigned * For aseptic area production roles candidate must be able to obtain and maintain current aseptic gowning qualification * Able to stand for up to 8 hours a day (with occasional breaks) | |