Position Title: Viral Downstream III Work Location: Swiftwater PA, 18370 Assignment Duration: 12 Months
Work Schedule: Positions across 3 shifts (typically 6AM – 2:30PM, 2PM-10:30PM, 10PM – 6:30AM). Flexibility required; overtime may be required. Some areas may require 12-hour shifts. All TPWs will start on day shift (typically 7AM – 3:30 PM or 11AM – 7:30PM) and will be moved to 2nd as needed in September/October.
Work Arrangement: Onsite (production floor in plant uniform)
Position Summary: • Large scale manufacturing environment. Work is on production floor in plant uniform (blues). • 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 requiring a high degree of relationship building, communication, technical knowledge, and leadership. • Background & Context: 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 Biologics Team, will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
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: • Integrity, Flexibility, Adaptability, Willingness and Ability to learn, Positive Attitude • 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. • 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 • 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. • Able to stand for up to 8 hours a day (with occasional breaks) • No vaccine requirement • 3 Areas (any prior experience, cell culture, aseptic technique, chromatography, etc. is a plus)
Buffer and Equipment Prep Area – Buffer Formulation, Equipment Preparation (Autoclaves, Parts Washers), Dock / Inventory work movement of materials and wipe downs, Environmental Monitoring Upstream – cell culture, working in Biosafety Cabinet (Strong Aseptic Technique or the ability to learn required), bioreactors Downstream – centrifugation, chromatography, tangential flow filtration • 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. • Physical Assessment/Clearance • Vision / Hearing
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $23.00/hr - $26.00/hr.
