Salary in Research Triangle Park, NC

Job DescriptionAbout This RolePerforms corrective and preventative calibrations on manufacturing and laboratory analytical instrumentation. 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.What You'll DoPerforms scheduled calibrations.Performs unscheduled corrective calibrations and repairs.Installs new instrumentation.Provides engineering and validation support.Authors changes to procedures, job plans, and LOTO safety formsWho You AreYou are a problem solver that works well in a team and with your knowledge and experience you can make a positive impact on production operations. You love learning new technological skills and want to make a difference in patients' lives. You efficiently manage time, have good organization skills, and maintain positive and professional attitude.QualificationsThis work requires occasionally climbing ladders, crawling into tight spaces, moving/lifting test equipment up to 50 lbs. as well as working in clean spaces where gowning is required. Ability to stand for up to 3 hours at a time is also required.Able to work 7AM to 3:30PM Monday to Friday but also able to work a rotation of 4 days a week from 2PM to 12AM in 10 hours shift system.Education and Experience:High School Diploma (or equivalent) + 2 years of direct GMP experience ORRelated Military experience (electronics preferred) and/or ISA Certification ORAssociate's Degree in I&C or EngineeringExperience with troubleshooting / investigating instrumentation and control issues.Knowledge of and experience with computerized maintenance management systems preferred.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9b991917-8543-4dbc-a987-35ba396d1a68

Job Description About This Role This critical member of the team supports both clinical and commercial manufacturing planning and finite scheduling activities for the RTP Drug Product and Drug Substance Manufacturing Sites; with a primary focus on the ASO/OSD operations. You will be responsible for creating and maintaining detailed and accurate daily production schedules that align with short & long term plans used by Manufacturing, Materials, Quality, Engineering, Validation and Plant Management teams. What You'll Do Execute planning scenarios/models to support site bulk DS/DP production plans, including input on ASO/OSD labor models.Analyzebottlenecks and build alternativesolutions Provideinput on equipment availability for facility readiness, changeover, maintenance, and shutdown project schedules; confirmingallresource requirements andtroubleshooting constraints Initiate and manage improvement projects to optimize planning processes and associated software systems (Infor). Lead project sub-team(s) to meet timelines and key deliverables (improvements in time, cost, quality, compliance standards) Collaborate withPlanning & Scheduling peers and other site-based Business Process Owners as well as with Global Network Strategy teams onlong-range planning Train and guide manufacturing operations team members on aspects of site scheduling functions and maintaining procedure Who You Are You are a biopharma manufacturing professional with excellent organizational and critical thinking skills. You are willing and able to own the finite scheduling of critical operations; constantly orchestrating the input and work of many cross-functional groups toward the common goal of schedule adherence and improvement. QualificationsBachelor's Degree (STEM preferred) plus 3 years of transferrable experience OR Associate's Degree (STEM preferred) plus 5 years of transferrable experience OR High School Diploma (or equivalent) plus 7 years of transferrable experience Demonstrated success in biopharmaceutical manufacturing scheduling and planning Very strong project management experience; keen ability to influence others in complex problem-solving situations Competency with manufacturing planning software platforms (Infor Advanced Scheduling preferred) Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9ba72eff-3d2d-4a15-a1e5-57a69286df5f

Job DescriptionAbout This Role The Facilities Site Services Sr. Associate II, Property Administration Specialist has the responsibility to maintain the site interior and exterior of Biogen buildings and rented space. Responsibilities include annual budget planning, PO management, Contractor program oversite, GMP cleaning oversite, pest control oversite, building remediation and support. All with safety first.What You'll Do GMP cleaning program oversitePest control oversiteContractor program oversiteMaintaining the site in a Fit for Manufacturing state (FFM). Facility and equipment exterior cleaning oversiteBuilding remediation and supportWho You Are Highly motivated individual, with the ability to multitask leading and managing team to complete critical GMP activities.QualificationsStrong GMP knowledge.Advanced education degree preferred.Five years working in Biotech or closely related industry.Trackwise and CMMS knowledge.Preferred Skills Site Services experience.GMP experience.People leader experienceAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bbb4c84-2749-4d61-a01a-73ec6f7961d4

Job DescriptionThe Coordinator IV, Manufacturing role supports the RTP Large Scale Manufacturing (LSM) Organization. Responsibilities include: coordinating changeover activities for manufacturing areas, assisting with authoring and revising standard operating procedures (SOPs), management of hoses, coordinate movement of equipment between manufacturing areas and offsite warehouse, and serve as the team's representative to various cross-functional projects and human performance/continuous improvement initiatives.What You'll DoChangeover: Coordinator will work with manufacturing, engineering and quality to facilitate changeover of a manufacturing area. Use Kneat to draft, review and approve electronic protocols. Use LIMs to generate sample labels and summary reports. Author/revise SOPs and perform SME assessments for GCCs as needed.Hose management: Coordinator will work with manufacturing, engineering and external vendors in procuring hoses. Use CMMS to onboard new hoses, monitor hose expiry and withdraw/retire hoses that are expired or no longer in use.Equipment Movement: Coordinator will work with manufacturing, engineering and warehouse to facilitate movement of equipment between manufacturing factories or to and from the offsite warehouse. Use CMMS to update equipment status and location.Team Representative: Participate in meetings that may require support from the Manufacturing Coordination Team (ie. daily integrated working team meetings, Fit-For-Manufacturing (FFM)/Invasive PMs meetings, GCC Review Board (CRBs), Tech Transfers, Facility Shutdown Planning,etc.)Human performance: Use Devonway to review open reports, workflow interrupters and continuous improvement ideas submitted by manufacturing. Coordinator may also provide support with implementation of continuous improvement ideas.Who you areYou have a developing understanding of the manufacturing process, including manufacturing support activities. You have a good base of technical knowledge, including understanding relevant engineering and scientific concepts as well as basic biotechnology process. QualificationsRequired skillsBachelors Degree with 2 years of transferrable experienceAssociates Degree or Bioworks Certificate and 2.5 years of transferrable ExperienceHigh School Diploma (or Equivalent) and 3 years of transferrable experiencePossesses a base understanding of the manufacturing process, including manufacturing support activities.Understands the basic theory and concepts behind the process, including an understanding of the impact of their own area on upstream and downstream activities.Must be able to demonstrate the ability to work under the supervision of a senior team memberUnderstands basic biotechnology processing - purpose of major unit operations and microbial control conceptsAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bbd4f78-3458-4cfa-8e2b-0b21c3ab14b8

Job DescriptionAbout This RoleThis critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be responsible for the strategic and tactical oversight of batch documentation review, continual evaluation during batch production, as well as providing material acceptance decisions for production batches. Through your guidance, your team will ensure compliance to all applicable regulatory requirements and that all GMP activities consistently operate in a state of control so as to successfully undergo domestic and international regulatory agency scrutiny.What You'll DoManage a wide variety of compliance oversight activities expanding several quality subsystems to ensure the safety, efficacy, and purity of the products manufactured by Biogen in the SSM, FVM and Cell Banking areas.Plan, implement, and direct core functions of QA Managers and Supervisors related to site disposition management and all disposition-related activities. Provide assessment of batch acceptance and perform final batch disposition decision for clinical and commercial production batches.Proactively identify and resolve both technical and compliance issues/gaps, Quality system evaluations, and continuous improvement initiatives. Develop and implement aspects of various Quality Systems and system improvements.Analyze and present on departmental and site metrics for compliance. Track and trend key performance indicators and evaluate site performance against these KPIs. Communicate with the Head of Quality in regard to any concerns or risks at the site.Participate effectively in a leadership or membership role for both corporate, global, and site cross-functional teams as a representative of Quality Assurance. Ensure optimum team dynamics and results.Provide mentorship and training within and across site functions.Who You AreYou are an experienced and energetic leader that enjoys leading a Quality Assurance organization through deadline driven initiatives. You are unfazed by the challenges of a complex manufacturing floor and can effectively plan, communicate, and advocate for a "Quality Mindset" throughout all of operations.QualificationsBachelors Degree in a relevant Life Sciences or related discipline + a minimum of 10 years of transferrable experienceAdvanced knowledge of quality systems; particularly lot dispositioning, document lifecycle management, change control and exception managementA strong and successful foundation of experience formally leading Quality Assurance teams in Pharmaceutical or Biotechnology production settingDeep knowledge of FDA/EMEA regulations and complianceExpertise in solving complex problems or diverse scope Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc75f38-40b4-48c6-806c-ee30a0b82449

Job DescriptionThe Sr. Tech II, I&C 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 Validations and engineering activities when called upon. Authors changes to procedures and job plans when required.What You'll DoPerforms scheduled calibrations.Performs unscheduled corrective calibrations and repairs.Installs new instrumentation.Provides engineering and validation support.Authors changes to procedures, job plans, and LOTO safety forms.Who You AreYou are a problem solver that works well in a team and with your knowledge and experience you can make a positive impact on production operations. You love learning new technological skills and want to make a difference in patients' lives. You can effectively multi-task and have good organizational skills. You regularly seek greater responsibility and growth opportunities.QualificationsThis work requires occasionally climbing ladders, crawling into tight spaces, moving/lifting test equipment up to 50 lbs. as well as working in clean spaces where gowning is required. Ability to stand for up to 3 hours at a time is also required.Able to work 7AM to 3:30PM Monday to Friday but also able to work a rotation of 4 days a week from 2PM to 12AM in 10 hours shift system.Education and experience:High School Diploma (or equivalent) + 3 years of direct GMP experience ORRelated Military experience (electronics preferred) and/or ISA Certification + 2 years of relevant experience ORAssociate's Degree in I&C or Engineering + 2 years of relevant experienceBachelor's Degree in I&C or Engineering + 1 year of relevant experienceExperience working in a GMP regulatory environment preferredExperience with troubleshooting / investigating instrumentation and control issues.Working knowledge of equipment in the biotech/pharma industry preferred.Knowledge of and experience with computerized maintenance management systemsAbility to work on call.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc75f3e-8962-41a0-b8a2-53239ef2f4cb

Job DescriptionThis position will work alongside a Swing Shift Quality team and will work from 12 PM to 12 AM on a 2,2,3 schedule.What You'll DoAs a Sr. Supervisor at Biogen's Research Triangle Park (RTP) facility, you'll be a pivotal part of our Quality Assurance team. Your mission is to ensure compliance, drive excellence, and maintain product integrity. Lead Quality AssuranceDirect and develop team members.Coordinate and evaluate employees and perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures. Evaluate, schedule, and balance departmental workload with respect to assignments/responsibilities/personnel, management of projects, adherence to all regulatory licenses and regulations.Support the QA Manager/Sr. Manager/Associate Director for activities related to interviewing, hiring and training of employees, compliance with training policies, performance evaluations, and supporting resolution of employee-related issues.Optimize ProcessesEnsure Product Disposition documentation and other documents supporting batch disposition are compliant.Recommend changes to existing Quality systems and GMP processes (change control).Identify gaps in existing Quality systems, propose solutions to QA Management and perform job functions of the QA Manager/Sr. Manager/Associate Director as delegated. Assess batch acceptance and final batch disposition decision for clinical and commercial production batches and final QA approval of planned exceptions and investigations.Collaborate Across TeamsWork closely with Manufacturing and other support functions to troubleshoot compliance issues in real time during manufacturing operations. Escalate quality-related issues to Quality Management to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.Support Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections, as required. Maintain state of inspection readiness.Who You AreYou have a track record in leading teams in Quality Assurance and you thrive on leading your team to meet production and compliance guidelines. You tackle challenges head-on and propose effective solutions. You collaborate seamlessly with cross-functional teams.QualificationsBA/BS degree, preferably in relevant scientific or technical discipline.4 years of relevant life sciences experience within Quality Assurance and/or Quality related functions.Experience leading and developing a team.Can effectively lead change & complete initiatives aligned with the business.Ability to flex and respond to unexpected situations, demands.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc960bf-b7bb-4973-bb17-af4e4795212a

Job DescriptionThis individual contributor who will report to the Head of Facilities Engineering Technical Authority is accountable for the development and implementation of a comprehensive reliability program that ensures the reliability, availability, and maintainability of our facilities, equipment, and systems across Biogen's global manufacturing network. You will lead functional development, maintenance, continuous improvement, and administration of the global Reliability Engineering program (including End of Life, Single Point of Failure, etc.) including business process ownership, best practices, standards, global program/procedure change management and enforcement. You will work closely with site reliability engineers to champion requirements and benefits; and monitors overall reliability performance at enterprise level in conjunction with individual site reporting from site reliability engineers. You will also develop data-driven technical analysis and/or program recommendations from common reliability engineering KPI's such as mean time between failures, mean time to repair, overall equipment effectiveness, failure rate, availability, maintenance costs, mean time between maintenance, equipment downtime, mean time between loss, cost of unplanned downtime, etc. This is a hybrid role to be based in RTP, NC.Key responsibilities categorized as follows: Program Management / Standards Develop and implement a global reliability program that ensures the reliability, availability, and maintainability of facilities, equipment, and systems across our global network Lead and manage the reliability program across all sites, providing guidance and support to site-level reliability teams. Develop and implement strategies to continuously improve equipment and system reliability, reducing downtime and maintenance costs. Develop and manage the reliability budgets, ensuring that resources are allocated effectively to achieve program goals. Develop and maintain relationships with external vendors and industry experts to stay up-to-date on new technologies and best practices related to reliability. Co-develop data management needed for track and trend program with CMMS BPO and System Admin Data Analysis / Continuous Improvement Develop and implement a data-driven approach to reliability, including the use of analytics, data visualization, and predictive maintenance tools. Monitor and report on program performance, using key performance indicators to track progress towards program goals. Ensure compliance with regulatory requirements, industry standards, and company policies related to reliability. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements. Perform functional equivalency assessment of spare parts. Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Capital Planning Collaborate with cross-functional teams to ensure that reliability is integrated into the design, construction, and operation of new facilities, equipment, and systems. Develop business case for improvements requiring investments and participate in capital planning for reliability related project opportunities. QualificationsRequired:BS in engineering (mechanical, electrical, chemical, industrial) or related facilities engineering discipline At least 6-8 years' experience in Facilities Engineering (or related maintenance, facilities, engineering experience) in Biotech, Pharma or equivalent industry Knowledge of Reliability Engineering / Program Management including asset lifecycle management practices; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning/qualification/validation Knowledge and application of PDMA, FDA and EMEA regulations Ability to influence individuals at both site and enterprise level Strong communication and presentation skills Strong understanding of reliability engineering analytic concepts and methods Established network of technical leaders, peers, and stakeholders in life science industry; actively participates in industry forums, etc. Knowledge of CMMS and engineering & maintenance business practices / procedures Knowledge of laboratory and pharmaceutical process support equipment Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project. Knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics. Good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Preferred:Knowledge of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) Knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable. Membership of relevant professional / technical organizationAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc960c1-8fbc-4a3f-a65c-e16141c28446

Job DescriptionAbout This RoleThe Sr. Engineer I, Automation 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 Sr Engineer I, Automation prioritizes between supporting the site and managing their assigned projects and tasks.What you'll doSystem Design and ImplementationSpecify, 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 Control System IntegrationSpecify and select appropriate instrumentation for process monitoring and control.Integrate various control systems and devices to ensure seamless communication and coordination.Troubleshoot and resolve issues related to control system integration.Validation and ComplianceEnsure all automation systems comply with regulatory requirements, including cGMP (current Good Manufacturing Practice) standards.Participate in validation activities, including writing and executing validation protocols.Maintain documentation in accordance with industry and company standards.Provide technical assistance to site quality systems through investigations, control system assessments, and corrective/preventative support to ensure a compliant GMP workplace.Work with the Site Quality units to ensure deviations and CAPAs are completed ensuring due dates are met in a timely manner.Continuous ImprovementIdentify opportunities for process optimization, reliability improvement, and cost reduction through automation.Implement changes to enhance system performance and reliability.Stay abreast of industry trends and emerging technologies to recommend improvements.Troubleshooting and MaintenanceProvide technical support diagnosing and resolving automation systems issues in a timely manner.Develop and implement preventive maintenance procedures for control systems.Participate in on-call rotation for technical issues.Possible night shift support when/if needed in the future.Collaboration and CommunicationCollaborate with cross-functional teams, including process engineers, validation specialists, and maintenance teams.Provide training to operations and maintenance personnel on control system functionalities.Operating expense and small capital projects supportPrepare project estimates for control/automation design, equipment, installation, labor, materials, and other related costs. Prepare project forecasts and schedules and tracks costs.Concurrently manage and execute or participate as a team member on multi-disciplined automation and controls capital and operating expense projects from inception to project completion in support of site operations insuring safety, regulatory compliance, company standards, operational requirements and business needs are met.Ensure selection of new control system equipment and instrumentation assuring it meets all regulatory requirements and all instrumentation is correct for the intended use.Perform a lead role with site technical departments to develop standards for control systems and instrumentation for new and existing equipment.Who You AreA self- starter and self-motivated individual who drives results and leads change. You are very organized and thrive working in a dynamic environment where strong technical knowledge and execution are required.QualificationsBachelors Degree (Electrical, Computer, Chemical, Mechanical Engineering or a related discipline).Minimum 4-6 years hands on experience in process control/automation, preferably in the pharmaceutical industry.Experience with Rockwell PLCs and HMIs, Wonderware System Platform/ Archestra, SQL databases management, Networking and Communication protocols, Microsoft Server configuration and administration.Experience with validation processes and documentation: Writing user requirements, system functional/design documents, and test protocols experience.Must be willing to participate in an on-call rotation and possible shift coverage.Understands risks and associated controls with working in electrically classified areas.Preferred QualificationsSiemens PLCs and HMIs experience is a plus.Manufacturing Execution Systems experience is a plus.Pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment experience.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc960c2-6cb2-49eb-9890-4a44621a3025

Job DescriptionThe Quality Technical Services & Compliance (QTSC) Senior Associate II is responsible for understanding quality systems, contributing to oversight of quality systems, and for the oversight of key functional and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The Senior Associate II will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality System cross-functionally.What You'll DoReview and approval of facility, utility, equipment, analytical instruments and automation lifecycle documentation including User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews.Provide cGMP guidance and quality risk management support of manufacturing on the floor issues with equipment or systems, including review and approval of deviations and Corrective/Preventive Actions (CAPAs).Review and approval of changes affecting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, materials/components, and business processes associated with IT GMP computerized systems.Support the site changeover program by providing oversight of multi-product equipment inspection and release including the review of changeover documentation, sampling, elastomer replacement, carry-over calculations, engineering configuration, summary reports and equipment release.Support site capital projects by providing GMP guidance, risk management input and quality oversight during shut down planning, release and other major equipment/facility improvements.Review and approve GMP Preventive/Corrective maintenance work as applicable.Lead investigations and CAPAs including driving Continuous Improvement initiatives.Proactively identify and resolve both technical and compliance issues/gaps.Develop and implement aspects of various Quality Systems/System Improvements.Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions.Who you AreYou are a motivated QA expert with sound Drug Manufacturing/Engineering experience/knowledge who is capable of being flexible with changing priorities. You are detailed oriented, a strong critical thinker and can work across multiple levels of the organization. You are truly a team player, knowing that when the team succeeds, we all succeed. You have a high level of personal accountability and are able to constructively hold peers and stakeholders accountable to their commitments. QualificationsBachelor's Degree, preferably in Engineering, Life Science or Technical discipline.6 years of relevant industry experience.Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and International Council for Harmonization (ICH) guidelines.Thorough Knowledge of Quality Engineering Systems (Facilities, Utilities, Maintenance, Engineering, Validation, and Automation).Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with technical and senior management staff.Experience in managing multiple, competing priorities in a fast-paced environment and dealing with ambiguity.Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate or high complexity.Preferred SkillsThorough knowledge and/or previous experience with cGMP Drug Substance or Drug Product Manufacturing environments.Ability to evaluate compliance issues and interact with regulatory inspectors.Experience in QA oversight of manufacturing, analytical and engineering activities.Experience in investigations, change controls, and CAPAs processes system knowledge.General knowledge of Project Management competencies obtained through relevant PM training or experience.General knowledge of industry best practices including ISPE Baseline Guide 5, GAMP5 and ASTM E-2500.Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems) preferred.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bcb6472-989f-4eb0-9764-04596d996cdc