Job Title: Fermentation Technician IV/V Day ShiftJob Description
The Senior Fermentation Manufacturing Technician (Tech IV/Tech V) supports commercial biologics production in a GMP-regulated facility, acting as a technical leader for upstream fermentation operations on the manufacturing floor. This role combines advanced hands-on operation of large-scale fermentation systems with real-time troubleshooting, training of junior technicians, and active participation in process improvement, deviation investigations, and operational readiness activities. The position operates on a day shift schedule with flexibility to support critical manufacturing activities in a 24/7 environment.
Responsibilities
- Execute upstream fermentation manufacturing processes in accordance with cGMP requirements, batch records, and approved procedures.
- Independently operate, monitor, and troubleshoot large-scale fermentation and associated upstream processing equipment, including single-use and stainless-steel bioreactors.
- Perform complex manufacturing activities such as reactor inoculation, process monitoring, sampling, harvest support, media preparation, and changeover activities.
- Monitor critical process parameters and make appropriate operational decisions within approved process limits to maintain product quality and process performance.
- Serve as a subject matter resource during manufacturing campaigns and critical processing activities, providing on-the-floor technical leadership.
- Provide real-time technical support and guidance to manufacturing technicians during routine operations and non-routine events.
- Mentor and train junior operators on process execution, GMP documentation practices, equipment operation, and troubleshooting techniques.
- Support onboarding and qualification of new manufacturing personnel, including participation in hands-on training and skills assessments.
- Assist in developing training materials, best practices, and operational standards to drive consistency and excellence in manufacturing operations.
- Lead or participate in root cause investigations related to deviations, process excursions, equipment issues, and manufacturing events.
- Drive continuous improvement initiatives focused on safety, quality, yield, throughput, and operational efficiency in upstream operations.
- Identify process improvement opportunities and support implementation of corrective and preventive actions (CAPAs).
- Partner with Engineering, Quality, MSAT, Validation, and Technical Operations on process improvements and operational readiness activities.
- Review and execute GMP documentation, batch records, logbooks, and electronic manufacturing records with a high degree of accuracy and completeness.
- Support deviation investigations by providing technical expertise and detailed input during event assessments and documentation.
- Ensure all manufacturing activities maintain inspection-ready compliance standards and align with regulatory expectations.
- Assist with authoring and revising SOPs, work instructions, manufacturing records, and training documents to reflect current practices.
- Support process validation, equipment qualification, PPQ campaigns, engineering runs, and technology transfer activities for new or modified processes.
- Participate in operational readiness exercises and manufacturing startup initiatives, including facility expansion and new line start-up support.
- Assist cross-functional teams with manufacturing scheduling, resource planning, and campaign execution to meet production goals.
- Demonstrate strong attention to detail, safety awareness, and a commitment to operational excellence in all daily activities.
Essential Skills
- High School Diploma or GED with at least 8 years of GMP biomanufacturing experience for Tech IV, or at least 10 years of GMP biomanufacturing experience for Tech V.
- Associate degree with at least 6 years of GMP biomanufacturing experience for Tech IV, or at least 8 years of GMP manufacturing experience for Tech V.
- Bachelors degree in Life Sciences, Engineering, Biotechnology, or a related discipline with at least 4 years of GMP manufacturing experience for Tech IV, or at least 6 years for Tech V.
- Extensive hands-on experience in GMP biomanufacturing, specifically supporting upstream fermentation and bioprocessing operations.
- Demonstrated ability to independently operate and troubleshoot large-scale bioreactors and fermentation systems in a commercial manufacturing environment.
- Experience with both single-use and stainless-steel bioreactors and upstream processing equipment.
- Advanced understanding of cGMP manufacturing requirements and regulatory expectations for commercial biologics production.
- Strong troubleshooting and root cause analysis skills with the ability to assess process conditions and recommend appropriate corrective actions.
- Proven leadership capabilities, including coaching, mentoring, and serving as a technical resource for junior technicians and peers.
- Experience reviewing and executing GMP documentation, including batch records, logbooks, and electronic manufacturing records with high accuracy.
- Ability to manage multiple priorities in a fast-paced commercial manufacturing environment while maintaining quality and compliance.
- Strong verbal and written communication skills to effectively interact with cross-functional teams and document activities.
- Demonstrated commitment to safety, quality, and operational excellence in a regulated manufacturing setting.
Additional Skills & Qualifications
- Extensive experience supporting microbial fermentation and upstream biologics manufacturing operations.
- Previous experience serving as a lead operator, trainer, mentor, or shift technical resource in a manufacturing environment.
- Experience supporting process validation activities, including PPQ campaigns and engineering runs.
- Experience participating in technology transfer activities for new products or processes.
- Experience supporting manufacturing startup or facility expansion efforts and operational readiness exercises.
- Knowledge of automated manufacturing systems such as MES, DeltaV, SCADA, or Distributed Control Systems (DCS).
- BioWork Certification or equivalent biotechnology manufacturing training.
- Experience working in biologics, vaccine, CDMO, or biotechnology manufacturing environments.
- Demonstrated success working cross-functionally with Manufacturing, Quality, Engineering, Validation, and Technical Operations teams.
- Strong critical thinking skills with the ability to quickly evaluate process data and make sound decisions.
- High level of attention to detail and organization to ensure accurate documentation and efficient execution of complex manufacturing activities.
- Interest in continuous learning, cross-training, and professional development within a commercial biomanufacturing setting.
- Motivation to grow into expanded responsibilities through a long-term contract role with potential for extension and advancement.
Work Environment
This role is based at a biopharmaceutical manufacturing facility in the RTP / Triangle Area and supports commercial biologics production in a GMP-regulated environment. The position is a Senior Fermentation Manufacturing Technician (Tech IV / Tech V) on a day shift schedule, following a standard daytime work pattern with the flexibility to support critical manufacturing activities as needed in a 24/7 operation. The assignment is structured as a long-term contract with potential for extension, offering opportunities for cross-training and advancement. Work takes place on the manufacturing floor around large-scale upstream fermentation equipment, including single-use and stainless-steel bioreactors and associated automated control systems such as MES, DeltaV, SCADA, or other Distributed Control Systems. The environment is fast-paced, highly collaborative, and inspection-ready, requiring strict adherence to cGMP standards, safety procedures, and cleanroom practices. Team members interact regularly with Manufacturing, Quality, Engineering, MSAT, Validation, and Technical Operations, contributing to process validation, tech transfer, and startup activities. The culture emphasizes safety, quality, continuous improvement, and professional development within a modern commercial biomanufacturing setting.
Job Type & Location
This is a Contract position based out of Morrisville, NC.
Pay and Benefits
The pay range for this position is $45.00 - $48.50/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
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 Time Off/Leave (PTO, Vacation or Sick Leave)
Job Type & Location
This is a Contract position based out of Morrisville, NC.
Application Deadline
This position is anticipated to close on Oct 30, 2026.
Workplace Type
This is a fully onsite position in Morrisville,NC.
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