28 operator jobs found in Durham

Biogen About This Role We are seeking a new team member to support the Utility Operations Dept. in a GMP and Non-GMP environment. In this role you will be responsible for operating the Plant Utility systems both GMP and Non-GMP, starting and stopping various utility systems using a BMS and DeltaV control system, monitoring utility systems, responding to all alarms, and performing rounds which include taking daily log readings on various utility systems. Individuals in this team will become trained and skilled in all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision. What You'll Do Operate plant utilities under guidance of a qualified operator. These systems include: medium pressure boilers, chillers, glycol system, cooling towers, air compressors, waste neutralization and compressed air, fire suppression systems Operate the following GMP systems under guidance of a qualified operator: USP...

Biogen This is a full time on-site position with M-F business hours About This Role The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a mannerconsistent with site and Corporate policies, cGMP, safety, environmental and humanresources policies and procedures. This individual will assist with regulatory and third party audits, aid in the development and implementation of GlobalQualitySystems, and manage Quality projects and other...

Biogen Shift Information This is a Night shift position, working Mon-Thu 8PM - 6AM one weekandTue-Fri 8PM - 6AM PM the followingweek. As a Manufacturing Maintenance Technician III, you will provide customer-oriented service and support in a fast-paced manufacturing environment. You will perform corrective and preventative maintenance on manufacturing washers, autoclaves, centrifuge, Bioreactors, tanks, pumps, and other production equipment at our BioSite location. This position requires a solid understanding of manufacturing systems including mechanical, electrical and control principles. What You'll Do Collaborate with Responsible Engineers and Manufacturing personnel to troubleshoot equipment problems. Perform preventative and corrective work order maintenance. Assists in troubleshooting mechanical problems and work with outside vendors to resolve recurring issues. Follow Standard Operating Procedures in performance of assigned duties. Maintain...

Biogen About This Role: As a Senior IT Business Partner for Biogen's patient engagement initiatives, you will play a crucial role supporting digital patient engagement initiatives within the Patient Services IT team. In this position, you will act as a techno-functional bridge between business stakeholders and technical teams, ensuring seamless collaboration and understanding. You bring deep expertise in patient engagement processes and how technology supports the end-to-end patient journey. You will work closely with franchise leadership, Patient Services, Patient Access, and External Growth & Innovation teams to co-develop and execute a comprehensive digital and technology roadmap. This role is pivotal in shaping the future of patient engagement at Biogen, ensuring that innovative solutions are developed and implemented to enhance patient support and care. What You'll Do: Serve as the patient engagement process expert: Build deep knowledge of how Biogen supports...

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Biogen This position follows a traditional 2-2-3 format from 6a-6P ( Red Day 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...

Biogen About This Role This position is on a 12-hour rotation, Night shift on a 2, 2, 3 schedule This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions on our Large Scale Manufacturing Purification Team . The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments. What You'll Do Supervises Manufacturing Associates - observing/instructing, coaching, leading and developing staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives. Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity. Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff and...

Biogen About This Role Biogen studies highly complex, devastating, and burdensome diseases and there are still significant challenges in how we understand and treat them. In the Quantitative Sciences Development Organization we aspire to transform patients' lives by accelerating disease research using best in breed and emerging techniques. Leveraging applied machine learning and emerging technologies, we drive solutions to advance research, clinical care, and patient empowerment. We stand with our colleagues across Biogen developing pioneering treatments. We believe that now, more than ever, biology and technology should go hand-in-hand to better meet patient needs, while enabling a shift towards more prevention-focused, affordable, and equitable care. What You'll Do As a Machine Learning Engineer, Operations and Health Systems Research, you will: Design, develop, and implement complex end-to-end data pipelines, engineer features and disease models to...

Biogen About This Role: As the Head of Global Integrated Digital Execution & Automation Solutions, you will lead and coordinate the digital execution and automation engineering activities across capital projects, lifecycle management, and manufacturing operations. Your role will be pivotal in driving continuous improvement initiatives with a right-first-time mindset, ensuring all activities align with industry standards and Biogen's best practices. Reporting directly to the Head of Global Engineering, you will work closely with global and site functions to support Manufacturing Operations, Quality, and other key stakeholders, building global capabilities in a standardized and reliable manner. Your leadership will guide the development and governance of technical standards, propelling Biogen forward in the digital arena. You will be instrumental in fostering strategic partnerships and ensuring compliance with regulatory and safety guidelines, thereby enhancing Biogen's...

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Biogen About This Role: As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility. Your expertise in GMP activities ensures that our quality systems remain compliant with industry standards. You will lead the charge in managing site inspections, regulatory requests, and overseeing the creation and approval of GMP documents. Your ability to balance departmental workload, mentor team members, and manage key projects will significantly contribute to our team's success. This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment to quality and excellence. What You'll Do: Manage regulatory and partner inspections, ensuring timely inspection setup, support, and closure Lead inspection readiness activities, including planning and execution Process regulatory requests to support submissions and approvals...

Bug Out Benefits Start Day 1 for Full-Time Colleagues - No Waiting Period! For more information about our benefits, see below! We are proud to be a member of the Rentokil family of companies, the global leader in Pest Control and other services across more than 90 countries. We pride ourselves on being a trusted partner to many of the world's leading brands and serve consumer and business customers across multiple industries. We are extremely proud of our legacy of excellence and constantly work to fulfill our mission to "protect people, enhance lives, and preserve the planet." What do our Innovation/Utility specialists do? The primary purpose of this role is to perform the dynamic combined aspects of pest control, exclusion services, minor construction, and TAP ( T hermal A coustical P est) insulation installation allowing you to make a significant impact in the communities we serve. Responsibilities include but are not limited to the following: Pest...

Biogen Position schedule: 2nd shift The schedule for this position can be either Tues-Fri 2PM to midnight OR Mon-Fri 2PM to 10PM (dependent on applicant preference). There is a rotational on-call schedule for weekends for this position. *MUST be available to work day shift while training for approximately 6 months About This Role The Sr Tech II performs corrective and preventative calibrations on manufacturing and laboratory analytical instrumentation with limited supervision. Supports manufacturing and laboratory personnel in the use, maintenance and repair of on-site instrumentation and test equipment. Supports Validation and engineering activities when called upon. Authors changes to procedures and job plans when required. What You'll Do Performs scheduled calibrations Performs unscheduled corrective calibrations and repairs Installs new instrumentation. Provides engineering and validation support Authors changes to procedures, job plans, and LOTO...

Biogen Shift:2,2,3 night shift (6 PM - 6 AM) About This Role In the dynamic role of Sr. Materials Handler II, you will be an integral part of our manufacturing team, responsible for the efficient handling of raw materials, processing manufacturing orders, and overseeing weighing and dispensing activities. This position focuses on receiving and shipping final drug substances, ensuring a seamless flow of materials that directlysupportsour productionobjectives. Your efforts willmaintaina safe, efficient, and productive environment at every stage, contributing significant value to our operational success.You'llmanage the receipt of GMP items, verify inventory against specifications, and ensure thetimelymovement of materials using our electronic inventory system. As a trusted member of our team, you will play a crucial role in liaising with various departments, ensuring accuracy and consistency in our supply chain processes. WhatYou'llDo Receive all GMP items, verifying...

Biogen About This Role As a Senior Process Engineer , you will be a key technical authority and Subject Matter Expert (SME) within the Drug Product Engineering Technical Authority . This role is responsible for driving technical excellence across a global manufacturing network, with a specific focus on Oral Solid Dosage (OSD) technologies. We are ideally looking for a strategic engineer with a background in Engineering Consultancy (A+E) who understands the intersection of process design, technologies, equipment and facility architecture. You will ensure the optimal design performance, scalability, and compliance of OSD systems, collaborating with site engineering function to drive modality development, enhancement, and global alignment. This is a hybrid role to be based at our offices in Research Triangle Park, NC. What You'll Do Establish and update engineering standards and best practices for all manufacturing sites, covering both Oral Solid Dosage (OSD)...

Biogen *Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts ( Days 6a to 6p) on a2-2-3 calendarrotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating...

Biogen **Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts ( Days 6a to 6p) on a2-2-3 calendarrotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). U Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned. What You'll Do Review test data in LIMS Prepare quarterly EM/UM reports Supports testing for all qualification and study directed testing Troubleshoot complex assays Perform microbiology testing...