GMP Cell Processing Specialist III
3 days ago
Winston-Salem
Job DescriptionJob Title: Manufacturing Cell Processing Specialist III Job Description The Manufacturing Cell Processing Specialist III plays a key role in advanced cell therapy manufacturing operations, with a primary focus on cell processing activities and strict adherence to cGMP guidelines. This position operates and maintains specialized production equipment, performs final product freezing and storage, and drives continuous improvement across manufacturing processes. The specialist mentors team members, leads investigations into deviations and CAPAs, and ensures consistently high levels of quality, compliance, and safety within a cleanroom environment. Responsibilities • Lead and oversee day-to-day cell processing activities while ensuring full compliance with cGMP guidelines and internal manufacturing standards., • Read, interpret, and implement Standard Operating Procedures (SOPs) for all assigned tasks, and provide clear guidance and training to team members on proper execution., • Set up, operate, monitor, and troubleshoot production equipment such as controlled rate freezers, orbital shakers, and related systems to ensure optimal performance and reliability., • Perform final freezing and storage of cell therapy products in liquid nitrogen (LN2), following established procedures to maintain product quality and integrity., • Revise, update, and maintain SOPs, batch records, and manufacturing forms to ensure they remain current, accurate, and aligned with GMP requirements., • Ensure adherence to Good Documentation Practices by accurately completing GMP documentation, including batch records, logbooks, and forms., • Lead routine cycle counts and manage accurate inventory tracking and control of materials, components, and supplies used in manufacturing., • Execute transactions within the ERP system, including material requisitions, inventory movements, and production tracking, to maintain real-time data integrity., • Lead or actively participate in investigations into deviations, incidents, and nonconformances, compiling data and documentation to support root cause analysis and Corrective and Preventive Action (CAPA) activities., • Drive continuous process improvement initiatives by identifying opportunities to optimize workflows, enhance efficiency, and strengthen quality and compliance., • Conduct aseptic manufacturing processes in a cleanroom environment, consistently applying aseptic technique and sterile processing practices to prevent contamination., • Perform environmental monitoring, decontamination, and cleanroom maintenance activities in alignment with established procedures and regulatory expectations., • Troubleshoot technical and process-related issues in cell processing, equipment operation, and documentation, escalating and resolving problems in a timely manner., • Ensure all manufacturing activities comply with applicable safety policies, rules, and regulations, and actively promote a safe working environment., • Collaborate cross-functionally with quality, engineering, and other operational teams to support technology transfer, process validation, and ongoing manufacturing readiness., • Mentor and support less experienced staff by sharing technical expertise in cell culture, aseptic operations, and GMP manufacturing practices.Essential Skills, • Preferred minimum of 4–6 years of relevant experience in cell processing, biotechnology manufacturing, or a closely related field., • 2–3 years of proven experience working in a cGMP-regulated manufacturing environment., • Hands-on experience with aseptic technique, aseptic operations, and sterile processing in a cleanroom setting., • Practical experience in cell culture, cell biology, and related laboratory methods., • Working knowledge of molecular biology concepts as applied to cell-based manufacturing processes., • Demonstrated proficiency with controlled rate freezers, orbital shakers, and other cell processing production equipment, including basic troubleshooting., • Strong understanding of cGMP principles, Good Documentation Practices, and batch record completion., • Experience with SOP execution, revision, and adherence in a regulated environment., • Ability to conduct and document environmental monitoring and decontamination activities in a cleanroom., • Proficiency in executing and reviewing batch records and associated GMP documentation., • Ability to exercise independent judgment, take ownership of tasks, and lead teams within manufacturing operations., • Strong computer skills, including proficiency with Microsoft Office applications., • Experience working with ERP systems for material management, inventory control, and production tracking., • Advanced organizational, record-keeping, and time management skills with high attention to detail.Additional Skills & Qualifications, • AS or BS degree in Biotechnology, Biology, Chemistry, or a related scientific discipline is preferred., • A science-related discipline is strongly valued for understanding complex cell therapy processes., • Relevant industry experience may substitute for formal education where appropriate., • A high school diploma or equivalent may be considered with significant and directly relevant experience in cell processing or biotechnology manufacturing., • Experience in medical device or related regulated industries is beneficial., • Familiarity with laboratory operations, including equipment handling, decontamination procedures, and general lab safety., • Experience with environmental monitoring programs in cleanroom or controlled environments., • Strong troubleshooting skills for both process and equipment-related issues., • Ability to contribute to deviation investigations and CAPA development through data compilation and analysis., • Effective communication skills to collaborate across functions and to mentor and train colleagues.Work Environment This role operates in both laboratory and office settings, with a significant portion of time spent in a controlled cleanroom environment. The cleanroom includes ISO-equivalent 10k and 100k areas, requiring strict adherence to sterile gowning procedures and the ability to maintain gowning certification. Work involves aseptic manufacturing, sterile processing, environmental monitoring, and handling of cell therapy products, including final freezing and storage in liquid nitrogen. Standard work schedule is Monday through Friday, with assignment to either a 7:00 AM–3:00 PM shift or a 10:00 AM–7:00 PM shift based on experience and operational needs. The environment is highly regulated, safety-focused, and quality-driven, utilizing specialized production equipment, ERP systems, and standard office productivity tools to support advanced cell therapy manufacturing. Job Type & Location This is a Contract to Hire position based out of Winston Salem, NC. Pay and Benefits The pay range for this position is $32.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
