41 jobs found

Biogen Job Description The Associate II, Quality Control is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen manufacturing facility. What you'll do: Perform testing including (but not limited to): Membrane filtration bioburden Kinetic turbidimetric assay (KTA) and kinetic chromogenic (KCA) endotoxin Growth promotion testing (GPT) Biological Indicator testing Microbial identification The Associate II responsibilities include, but are not limited to, training, testing support for drug substance and drug product, support for qualification and validation activities as appropriate, robust, and Associate II should possess a fundamental understanding of the Biogen Quality Systems and apply it in their daily support functions. Additional responsibilities include adherence to all GLP/GMP requirements, a basic understanding of FDA/EMA regulations. The Associate II should have effective...

Biogen Job Description Schedule: this position will work 4-day, 10-hour shift Sunday-Wednesday from 8 AM to 6 PM. The Associate II, Quality Control is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen manufacturing facility. What you'll do: Perform testing including (but not limited to): Membrane filtration bioburden Kinetic turbidimetric assay (KTA) and kinetic chromogenic (KCA) endotoxin Growth promotion testing (GPT) Biological Indicator testing Microbial identification The Associate II responsibilities include, but are not limited to, training, testing support for drug substance and drug product, support for qualification and validation activities as appropriate, robust, and Associate II should possess a fundamental understanding of the Biogen Quality Systems and apply it in their daily support functions. Additional responsibilities include adherence to all GLP/GMP requirements, a...

Lead Field Service Technician Status: Non-Exempt (hourly)                                                             Department: Field Service Position Summary The Lead Field Service Technician is responsible for the daily activities at a customer site, including but not limited to scheduling, delegating tasks, maintaining 5S standards, inventory, and maintenance of units. The Lead Technician will be the point of contact for training new hires and sets the standard for professionalism at the customer site. This individual will continue to support our fuel cell products currently installed in electric lift trucks, including performing preventative maintenance and resolving breakdowns. This person will maintain consistent communication with their respective Regional Service Manager to provide updates on the customers, technicians, and any issues at the site. This position presents a great amount of exposure to customer personnel and electric lift truck operators,...

Regional Service Manager Status: Exempt (salaried) Department: Service   Location: North Carolina or South Carolina Position Summary The Regional Service Manager is a key ambassador to our fuel cell system customers in the field. The RSM takes ultimate responsibility to ensure that a high-level of service is provided to support our customer sites and maintain the functionality of their installed fleet of Plug Power units. This role must set extremely high standards for customer service while working to embed this mindset within the performance output of direct report team members. The RSM must be both a technical subject matter expert and a role model for Plug Power’s customer relationship building. The RSM must also ensure the ongoing training and development of their team members both in their technical acumen and their customer service approach. This role is vital to supporting the strong reputation for the reliability of Plug Power technology as well as...

Biogen Job Description The Plant Engineer III provides engineering technical support and troubleshooting for plant utilities and facilities. Systems supported may include clean utilities (water, air, steam, gasses), HVAC air handlers (clean and office areas), steam systems, waste systems, tower water, and process glycol. The Plant Engineer III leads or participates in design, specification, installation, commissioning, and qualification of new equipment including URS and protocol writing and executions. This role partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance, and others to measure, target and improve reliability of all assets. What You'll Do Troubleshoot equipment systems and support associated automation (Building Management System) system troubleshooting efforts and involvement with group or department initiatives. Provide responsible engineering support for all areas of the buildings, manufacturing areas, labs and...

Description Summary/Objective The electrician is responsible for troubleshooting electrical problems and performing repairs based upon customer demand and need; and to provide complete customer satisfaction in a polite and professional manner. Requirements The primary responsibilities of an Electrician will include (but are not limited to): Works with inspectors to ensure all fuel and forecourt dispensing equipment/lighting is wired to code and installed properly. Pulls and/or wires conduit, wire dispensers, and breaker panels. Installs emergency stop systems and wires/installs lighting. Effectively analyzes problem situations pertaining to breakdowns and recommend to customer actions necessary to correct situation. Exhibits a professional demeanor and promotes goodwill between the company and customers by providing a superior level of customer service. Observes, analyzes, and determines corrective course of action for service and repair of customer equipment/fixtures....

Biogen Job Description About This Role The Head of Bio QA and Alliance Quality is a key member of the Site Leadership Team and has the overall responsibility for Global Quality Assurance operations at the RTP Bio site - including the Large Scale Manufacturing facility, Small Scale Manufacturing Facility, Flexible Volume Manufacturing, and Cell Banking operations. This position has a heavily strategic component, responsible for the relationships with senior management of key partner and joint venture organizations pertaining to site operations. This position is also responsible for oversight of the Quality strategy for the assigned Biogen contract and/or internal program, including partner audit management and audit responses as well as the management of regulatory inspections related to partner programs or products. This function has the responsibility to ensure the requirement of Global Quality System regulations are effectively established and maintained to provide...

Biogen Job Description Responsibilities of the QC Associate II include, but are not limited to, raw material testing support, protocol and report writing, robust and compliant cGMP documentation practices. A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions. The incumbent will be responsible for adherence to all GMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The incumbent should be able to work effectively within the group as well as independently to meet assigned timelines. Operate with integrity. What you'll do: Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures. Testing includes, but is not limited to: Bioburden, Endotoxin,...

Biogen Job Description This experienced Analytical Scientist will work in the Analytical Technology (AT) department supporting late-stage Small Molecule and Anti-Sense Oligonucleotide (ASO) development and commercial products. The AT team works in a GMP environment focusing on analytical method validation, transfers, investigations, method optimization, new technology implementation and supporting global regulatory filings. As a Scientist II, you will work collaboratively with Quality Control, Analytical Development (AD) within Pharmaceutical Development Organization, Manufacturing Science, Product Development Quality (PDQ), Regulatory, and external partners as well as contract manufacturing and testing organizations (CMO/CLO). You will represent the Analytical Technology group in CMC sub-teams as a subject matter expert responsible for leading method validation and tech transfer activities, troubleshooting, investigation and optimization at the external partner site, and...

Biogen Job Description SHIFT: Mon-Fri 3:00 PM - 11:00 PM or 4:00 PM - 12:00 AM, depending on new hire's preference. No on-call or weekend work A Manufacturing Technician III performs preventative, standard and repair maintenance on process equipment and utility equipment, such as, bioreactors, water and CIP systems, pumps, agitators, gearboxes, bearing replacements and all mechanical equipment repairs. Often assigned to design and come up with creative solutions to small projects and redesigns on troublesome components and systems. Assist in training all of the manufacturing technicians when required and serves as a lead technician in providing troubleshooting expertise for autoclaves, glasswashers and other support equipment and off hours on-call maintenance coverage as needed. What You'll Do Performs preventative and corrective work order maintenance. Assists in troubleshooting mechanical problems. Works with outside vendors to resolve recurring issues....

Biogen Job Description About This Role This key leadership role leads the Biogen Small Molecule and ASO Engineering Technical Authority function, which is accountable for engineering subject matter expertise in small molecule and antisense oligonucleotide (ASO) modalities. Technical Authorities possess a comprehensive understanding of the entire asset lifecycle, which encompasses performance, design, qualification, operation, maintenance, and reliability requirements. This Senior Director will report to the VP of Global Engineering and manage a team of subject matter experts that effectively contribute to all stages of the asset's lifespan: ensuring standards, specifications, and strategic approach to manage the optimal lifecycle of the asset. What You'll Do Leverage industry-leading subject matter capabilities in small molecule and ASO engineering to create an aligned strategic technical direction for Biogen sites, external development and manufacturing operations,...

Description Summary/Objective: Under the direct supervision of the Construction Manager, this entry-level position provides administrative support for the Construction department. Essential Job Functions: Review jobs for billing accuracy. Strong attention to detail. STRONG punctuality is a MUST!! Enter time worked for Construction personnel in Great Plains – Time Track software. Issue and receive Purchase Orders. Commission/Register new equipment installed. Review denied/past-due invoices. Obtain multiple trip approval for billing purposes. Assist construction manager with ordering equipment, setting up jobs and reviewing jobs for close out. Additional Eligibility Qualifications: Strong attention to detail. Good knowledge of Excel/MS Office. Good at multitasking and prioritization. STRONG punctuality is a MUST!! Excellent verbal and written communication skills required. Excellent interpersonal skills required. Self-starter with focus on process...

Biogen Job Description The Sr. Plant Engineer I provides engineering technical support and troubleshooting for plant utilities and facilities. Systems supported may include clean utilities (water, air, steam, gasses), HVAC air handlers (clean and office areas), steam systems, waste systems, tower water, and process glycol. Leads or participates in design, specification, installation, commissioning and qualification of new equipment including URS and protocol writing and executions. This role partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance and others to measure, target and improve reliability of all assets. Role also requires use of the Computerized Building Management System for troubleshooting and improvements. What You'll Do: Troubleshoot equipment systems and support associated automation (BMS) system troubleshooting efforts and involvement with group or department initiatives. Support equipment related capital and op-ex...

Biogen Job Description The Reliability Engineer III drives the implementation of the site Reliability strategy for all assets. Applies Reliability Engineering methodologies to optimize design requirements and performance of critical assets across the site. Originates and develops analysis methods for determining reliability of components, equipment and processes. Prepares data and communicates information to define reliability problems, recommend improvements and avoid failures. What You'll Do Work across multiple site functions to ensure the reliability and maintainability of new and modified installations. Help establish and integrate reliability targets into functional specifications for new equipment. Develop testing protocols, participate in factory and site acceptance testing as needed and interpret reliability testing results. Perform detailed analyses of site manufacturing and utilities process equipment to establish and implement reliability strategies (RCM)...

Biogen Job Description This role directs the activities of facilities engineering staff and is accountable for the installation, commissioning, qualification, validation and optimization of all infrastructure and utilities equipment including HVAC, electrical distribution, steam generation, qualified utilities such as WFI, clean steam gases and all associated controls. This role also leads troubleshooting efforts using best practice tools to understand and correct the root cause of failures. Effectiveness in this role requires excellent communication, influence and collaboration skills to partner with multiple disciplines and departments to drive equipment reliability and cost optimization of all utilities. What You'll do: Allocate and manage workloads in accordance with site priorities. This includes managing assigned compliance deliverables such as deviations, corrective and preventive actions, change controls, procedure updates and troubleshooting and optimization of...

Biogen Job Description The Project Controls Principal is a strategic member of Biogen's Global Engineering & Facilities Organization. Reporting to the Head of Capital Management, this individual will be responsible for creating and maintaining a strategic program for all relevant capital project controls and reporting elements. They will also partner on data collection and presentations to support portfolio processes (monthly portfolio reporting, annual operating plan, and long-range planning). The Associate Director will define and implement global project controls standards and guidance, keeping up-to-date and benchmarking against industry leading best practices. This role will be responsible for identifying and leading key project controls improvement initiatives to support business needs that ultimately make a bottom-line difference serving patients around the globe. What You'll Do Develop and manage performance metrics on front end planning during ideation and...

Biogen Job Description As a member of the Global Engineering & Facilities (GEF) leadership team, this individual will lead the Capital Management function. Reporting to the Head of Global Engineering & Facilities, this role will be responsible for creating and maintaining a strategic program for all relevant capital portfolio, capital planning, project management, and project control elements. This role will ensure successful front-end planning, execution, and delivery of the Pharmaceutical Operations & Technology (PO&T) capital portfolio in accordance with safety, quality, scope, cost, and schedule expectations from all relevant stakeholders. What You'll Do Hold accountability for the global large capital portfolio ($100M - $500M) for Biogen PO&T currently with drug substance and drug product facilities in North Carolina (USA) and Switzerland Manage the following sub-functions: Capital Portfolio Management, Capital Planning, Project Management, and...

Ameriprise Financial Responsible for effectively planning, designing, implementing and monitoring security technologies and projects that support the firms' underlying security policies and procedure in the PKI domain. Design, document and implement appropriate security policies and standards that protect the firms' information assets. Utilize highly technical and physical forensics to ensure that security policies, standards and best practices are followed throughout the technology organization-including where vendors are utilized to provide services. Note: We are also hiring for this role in Minneapolis, MN. Key Responsibilities: Drive the development of PKI solutions to meet security and business requirements. Develop automatic certificate provisioning solution with tools like F5, app servers (Apace\IIS), AWS ACM, AWS EKS, Azure, IBM DataPower, Connect Direct etc. Provide technical support for PKI and different certificate deployment implementations on multiple...