15 associate technical lead jobs found in Durham

Biogen What You'll Do The Sr Associate II will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, actions, and environmental excursions. The Sr Associate II must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion May provide Quality...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen This position follows a traditional 2-2-3 format from 6p-6a (Night Shift) About This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. In coordination with Supervisor, schedules tasks for a given shift and plan...

Merck Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. The Specialist, Manufacturing Automation, is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations at our Manufacturing Division Vaccine Manufacturing Facility located in Durham, NC. Additional Responsibilities Understands and supports all GMPs, safety, and environmental regulations | Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety. Develops and supports corrective actions associated with automation related deviations/investigations....

Merck Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. The Specialist, Manufacturing Automation, is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations at our Manufacturing Division Vaccine Manufacturing Facility located in Durham, NC. Additional Responsibilities Understands and supports all GMPs, safety, and environmental regulations | Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety. Develops and supports corrective actions associated with automation related deviations/investigations....

Merck Job Description Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products. This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations...

Merck Job Description Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products. This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. As the team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations...

Fidelity Investments Job Description: Note: Fidelity will not provide immigration sponsorship for this position As a Senior Cybersecurity Analyst, you will play a critical role in managing vendor-related cybersecurity incidents and driving risk mitigation strategies across the enterprise. You will lead efforts to monitor, assess, and respond to vendor security events, while coordinating reporting initiatives and collaborating with internal stakeholders. This role requires a strong understanding of third-party risk, incident response, and vendor lifecycle management. The responsibilities of this team include: Monitor and assess changing vendor risk profiles between review cycles and take appropriate action Coordinate with internal teams and external vendors to ensure timely and effective incident response Develop and deliver reporting packages in collaboration with ECS Product Lines and other stakeholders Apply cybersecurity principles to evaluate vendor...

Biogen This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems. Collaborating closely with QC teams, Quality, Planning, Warehouse, Validation, and Manufacturing teams, you will help ensure that operations run smoothly. Your role may also involve assisting with GMP compliance activities, investigation writing, and continuous improvement initiatives. By working independently and...

Biogen This role operates on a 8a-5p, M-F schedule About This Role As a Facilities Technician III, you will operate and repair including medium pressure boilers, HVAC, chillers, cooling towers, air compressors, Reverse Osmosis, WFI stills, Sterility Isolator, parts washers, fire monitoring systems, sprinkler systems, Bio safety cabinets, process waste streams, electrical systems including lighting, nitrogen compressed gas delivery systems. Furthermore, you will provide troubleshooting expertise on problem utility equipment and serve as system expert for the utility systems under guidance of other Technicians when necessary. What You'll Do Operateall utility systems that supply manufacturing. Trainothers as needed on operation and maintenance of utility systems and serveas system expert. Maintain and troubleshoot HVAC systems within the plant Maintainutility systems and respondto critical alarms. Logreadings on various plant equipment systems and investigatewhen...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...

Biogen Facilities Technician II The schedule for this role will be a 2 2 3 rotation, 7a-7p About This Role As a Facilities Technician II, your primary duties will be to operate, and repair chill water cooled GMP and non-GMP air handlers. Ability to troubleshoot motor control, perform bearing replacement and alignment, and valve replacement. Knowledge and understanding of steam, HHW and chilled water operational equipment, i.e. steam traps, check valves, control valves. In this role, you will be responsible for the operation, maintenance, and repair of chilled water-cooled air handling units (AHUs), including both GMP and non-GMP systems, as well as associated ventilation and exhaust systems. Key Responsibilities: Operate, maintain, and troubleshoot chilled water-cooled AHUs, exhaust fans, and related HVAC components. Troubleshoot air handler controls connected to Motor Control Centers (MCCs) and Programmable Logic Controllers (PLCs). Diagnose...

Biogen Facilities Technician II (Night Shift) The schedule for this role will be a 2 2 3 rotation, 7p-7a on Night shift About This Role As a Facilities Technician II, your primary duties will be to operate, and repair chill water cooled GMP and non-GMP air handlers. Ability to troubleshoot motor control, perform bearing replacement and alignment, and valve replacement. Knowledge and understanding of steam, HHW and chilled water operational equipment, i.e. steam traps, check valves, control valves. In this role, you will be responsible for the operation, maintenance, and repair of chilled water-cooled air handling units (AHUs), including both GMP and non-GMP systems, as well as associated ventilation and exhaust systems. Key Responsibilities: Operate, maintain, and troubleshoot chilled water-cooled AHUs, exhaust fans, and related HVAC components. Troubleshoot air handler controls connected to Motor Control Centers (MCCs) and Programmable Logic...

Biogen Job Title: Sr. Technician II, Instrumentation & Controls Schedule is Mon-Friday, 7a-330p About This Role: As a Sr. Technician II in Instrumentation & Controls, you will play a crucial role within the PO&T team by performing both corrective and preventative calibrations on a variety of manufacturing, facility, and laboratory analytical instruments. Your expertise will support manufacturing and laboratory personnel in maintaining the functionality and accuracy of critical equipment, ensuring seamless operations. You will often collaborate with engineering and validation teams to address equipment failures and support validation activities. By authoring changes to procedures and job plans, you will help refine our processes and maintain our high standards. This role is vital in minimizing downtime, enhancing productivity, and ensuring compliance with industry regulations, thereby supporting the overall business objectives. What You'll Do: Perform...

Biogen About This Role The Automation Engineer III provides 24/7 process controls/automation technical site support to the Biogen 900 Davis drive, NC manufacturing site. In addition, this role manages multiple small OPEX/CAPEX projects and continuous improvement initiatives that support the site from initial conception to final closure. The Automation Engineer III prioritizes between supporting the site and managing their assigned projects and tasks. What you'll do System Design and Implementation: Specify, design, develop, install, commission, and qualify process control and automation solutions in direct support of commercial and clinical manufacturing operations. Collaborate with cross-functional teams to understand process requirements and develop control system specifications. Configure and program Supervisory Control and Data Acquisition (SCADA), Programmable Logic Controllers (PLC), and Human-Machine Interface (HMI) systems. Instrumentation and...