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Leidos jobs in Fayetteville, NC - 73 jobs

  • CPI2 Fielder Sr.

    Leidos 4.7company rating

    Leidos job in Fayetteville, NC

    Join a team committed to a mission! At Leidos, we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customers' success. We empower our teams, contribute to our communities, and operate sustainable. Everything we do is built on a commitment to do the right thing for our customers, our people, and our community. Our Mission, Vision, and Values guide the way we do business. Are you ready for your next career challenge? CPI2 Fielder Senior will provide logistics support and execute fielding for CPI2 systems, working directly with the customer and overseeing small teams when needed. This opportunity will be located at Fort Bragg NC. The scope of work for these positions will evolve and transition throughout the lifecycle of the CPI2 program. Primary Responsibilities: Responsible for all phases of Army fielding process to include de-processing, inventory, hand-off and scheduling with Military users for hand-off (transition) of CPI2 systems to the unit Primary Hand Receipt Holder (PHRH). Will work under minimal supervision from the government customer Will serve as point person for projects to receive and distribute mission directives and assignments. Duties also include coordinating office space, equipment storage space, equipment movement, and execution of fielding for all systems. Reviews packing lists, receiving documents, bills of lading, inspection reports, and other actions for material receipts against contract orders to verify accuracy of equipment received, quantity, and other pertinent data. Receives, checks, visually and physically examines all incoming equipment, parts and process and accept these items for issue/storage/shipping. Communicates with respective Fielding Managers to inform them of issues, status and reporting of fielding effort(s) as required. Provides daily comprehensive reports regarding fielding issues. Efficiently and accurately communicates with the principal property and sub-account holders on procedures for replacement, transfer and turn-in of property items. Ensures all documentation is reflected accurately on DA Form 1348, DA Form 1149, and DA Form 2062. Ensures compliance with hand receipt holders on regulatory requirements of the Command Supply Discipline Program (CSDP). Ensures inventories are conducted for accountability and enforce regulatory compliance. Assist units in obtaining disposition instructions from Program Managers. Operates material moving equipment such as forklifts, manual pallet jack for inside and outside holding areas. Must have the ability to work as part of a team, or independently as required. Basic Qualifications: Bachelor's Degree with 3 or more years of experience or equivalent Military Occupation Specialty (MOS) in lieu of degree and 4 years of hands on experience on related TN (formerly WIN-T) systems. Familiar with C2OTM systems required. Must currently be on the Warfighter Readiness program or have prior experience with the Warfighter Readiness program. Active DoD secret security clearance. Technical understanding and experience with TN systems. Fundamental understanding of SATCOM, LOS, and Wi-Fi systems. Must have LAN and WAN networking experience (Net+, Sec+, CCNA, preferred). U.S. Passport required. Experience with Army logistics process. Ability to travel 50%. At Leidos, we don't want someone who "fits the mold"-we want someone who melts it down and builds something better. This is a role for the restless, the over-caffeinated, the ones who ask, “what's next?” before the dust settles on “what's now.” If you're already scheming step 20 while everyone else is still debating step 2… good. You'll fit right in. Original Posting:January 7, 2026 For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above. Pay Range:Pay Range $59,150.00 - $106,925.00 The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
    $59.2k-106.9k yearly Auto-Apply 2d ago
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  • Sr Analyst I, Materials

    Biogen Idec 4.9company rating

    Parkton, NC job

    Job Title: Sr. Analyst I, Material Planning About This Role: As a Sr. Analyst I in Material Planning, you will play a pivotal role in supporting manufacturing planning efforts at our RTP Pharma Manufacturing Site, focusing on both clinical and commercial programs. You will work closely with teams across Manufacturing, Warehouse, Scheduling, Quality, and Procurement to address raw material issues, manage scheduling conflicts, and ensure optimal inventory levels. Your role is integral to driving project success, as you resolve issues and report project status to both your team and management. With a keen eye on analyzing data to help reduce costs and mitigate write-offs. This position requires a balance of independent work and effective collaboration across all business areas and organizational levels. What You'll Do: * Manage raw materials planning and inventory control activities, including forecasted demand, stock levels, and expiry reporting. * Oversee weekly management of supply chain planning software and load firm planned orders. * Revise and maintain SOPs, and create BOMs, Formulas, Recipes, and various production and warehouse rules in OPM. * Analyze data in support of the new item creation process and Master Data enrichment * Review process and raw material vendor change notifications for inventory impact, facilitating cross-functional discussions to drive changes to closure. * Support tech transfers and manage manufacturing bills of materials to ensure raw materials are available to meet the manufacturing schedule. * Analyze data and create the Expired and Obsolete report quarterly, reviewing findings with the site planning management team. * Participate in site leadership team meetings and escalate potential issues to management when necessary. Who You Are: You are a detail-oriented professional with a passion for ensuring seamless material planning and inventory control processes. Your collaborative nature allows you to effectively work across various departments and levels of the organization. You possess strong analytical skills, enabling you to interpret data and provide insights for optimization. Your proactive approach ensures that potential issues are addressed promptly, contributing to the overall success of the projects you support. Required Skills: * Bachelor's degree, preferably in Supply Chain Management, Business Administration, or related field. * 3-5 years of experience in material planning or a related field. * Strong understanding of inventory control and raw materials planning. * Proficiency in using Oracle for creating and maintaining BOMs, Formulas, and production rules. * Excellent analytical skills with experience in data analysis and reporting. * Strong communication and collaboration skills. Preferred Skills: * Experience in the biotechnology or pharmaceutical industry. * Familiarity with supply chain planning software and Kanban setups. * Ability to manage tech transfers and support manufacturing schedules effectively. Job Level: Professional Additional Information The base compensation range for this role is: $75,000.00-$98,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to: * Medical, Dental, Vision, & Life insurances * Fitness & Wellness programs including a fitness reimbursement * Short- and Long-Term Disability insurance * A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) * Up to 12 company paid holidays + 3 paid days off for Personal Significance * 80 hours of sick time per calendar year * Paid Maternity and Parental Leave benefit * 401(k) program participation with company matched contributions * Employee stock purchase plan * Tuition reimbursement of up to $10,000 per calendar year * Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. 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.
    $75k-98k yearly 24d ago
  • Senior Manager Quality Assurance - Incoming Quality Raw Materials /Disposition

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryQualityJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager Quality Assurance - Incoming Quality Assurance Raw Materials /Disposition What you will do Let's do this! Let's change the world! In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Specific responsibilities include but are not limited to: Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations). Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements. Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring. Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations. Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays. Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact. Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program. Represent the Quality unit during internal and external audits and regulatory inspections. Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed. Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline. What we expect of you We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR Associate's degree and 10 years of Quality and Manufacturing support industry experience OR Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR Master's degree and 6 years of Quality and Manufacturing support industry experience OR Doctorate degree and 2 years of Quality and Manufacturing support industry experience Preferred Qualifications: Educational background in Life Science and/or Engineering Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems. In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice. Hands-on experience with Disposition, Incoming, and Quality Systems-particularly investigations, corrective actions, and audit readiness. Experience managing and interacting with regulatory and internal auditors. Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills. Effective risk management, negotiation, and cross-functional collaboration abilities. Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 154,692.00 USD - 188,725.00 USD
    $102k-132k yearly est. Auto-Apply 2d ago
  • Associate Manufacturing (Day Shift)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Manufacturing (Day Shift) Live What you will do Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. Please note; no relocation assistance will be provided for these positions. With general direction, the Associate will support all floor operations in accordance with cGMP practices. Responsibilities will include... Compliance: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance Assure proper gowning and aseptic techniques are always followed Process/Equipment/Facilities: Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area Run and monitor critical process tasks per assigned procedures Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) Complete washroom activities: cleaning equipment, small to large scale, used in production activities Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions Perform documentation for assigned functions (i.e., equipment logs, EBRs) Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities Maintain an organized, clean, and workable space Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications. Basic Qualifications: High School/GED + 2 years manufacturing and/or other regulated environment experience Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience Or Bachelor's Degree Preferred Qualifications: Completion of NC BioWork Certificate Program Experience in a regulated industry such as biotechnology or pharmaceutical Basic understanding and process experience in a cGMP manufacturing facility Excellent verbal and written communication Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible No relocation assistance will be provided for these positions Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 75,618.00 USD - 89,473.00 USD
    $26k-35k yearly est. Auto-Apply 3d ago
  • Manufacturing Specialist - Single Use Systems (SUS)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manufacturing Specialist - Single Use Systems (SUS) What you will do Let's do this. Let's change the world. In this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction, new technology and equipment introduction, continuous improvement projects, supporting CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance organization in Amgen North Carolina at Holly Springs. This role is critical for Amgen North Carolina's success and key in supporting single-use (SUS) operations. Support New Product introduction and projects through SUS mapping/drawing. Maintain and edit SUS Standard Operating Procedures (SOP). Support manufacturing and quality through the SUS defect/leak triage process - perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings. Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation. Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects. Provide input for ANC representative to SUS network for improvements and troubleshooting. Support Vendor Change Notification assessments. Understand single-use material capabilities and user requirements for new technologies through interaction with end users. Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting and flow. What we expect of you We are all different, yet we all use our unique contributions to serve patients. We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems, with the following qualifications. Basic Qualifications: High School/GED and 4 years of manufacturing or operations work experience OR Associate's Degree and 2 years of manufacturing or operations work experience OR Bachelor's Degree and 6 months of manufacturing or operations work experience OR Master's Degree Preferred Qualifications: Experience with and understanding of Single-Use Systems. Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent. Technical knowledge of drug substance processing and broad understanding of related disciplinary areas. Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms. Ability to coach, mentor and/or cross train colleagues within core technical area. Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities. Ability to drive results through leadership of cross-functional teams. Data analysis and/or data visualization skills Excellent writing skills. Presentation experience - presentation to leadership. Determines work tasks and timelines self-sufficiently - ability to navigate through ambiguity and prioritize effectively Proficiency in computerized systems for example, Smartsheet, excel, Trackwise, Veeva, Visio. Expertise with translating business/user needs to user requirements and recommend solutions. Experience in individually supporting key manufacturing systems with 24x7 operations. The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations. Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality. Pro-active, result oriented, and ability to prioritize work to meet timelines. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 88,378.00 USD - 106,188.00 USD
    $42k-58k yearly est. Auto-Apply 48d ago
  • Manager Manufacturing, New Product Introduction (NPI)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager Manufacturing, New Product Introduction What you will do Let's do this. Let's change the world. In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization. ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. This NPI team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality. Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development. Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. resources, platform technical understanding, cross-functional alignment). Lead team meetings and drive alignment in business processes across the team. Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products, process changes and improvements and/or advanced technologies into the plant. Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level. Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings. Drive a culture of inspection readiness across the team by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy. Interacts with management in planning, developing, and maintaining budget Assist in developing and maintaining department goals Interact with regulatory agencies as needed Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement Responsible for selection, training, evaluation, staff relations and staff development Mentor and coach staff members to live by the Amgen Values Develop and implement trainings plans and programs, to ensure staff are prepared and compliant Other functional responsibilities may be assigned What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Master's degree and 3 years of Manufacturing or Operations experience OR Doctorate degree Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry Experience leading/managing a team of direct reports Experience with PAS X, Werum software Experience in GMP operations, including New Product Introduction (NPI) Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc. Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Ability to coach, mentor and/or cross train colleagues within core technical areas Background in lean manufacturing methodologies and operational excellence Experience in cross functional Project Management What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 123,631.00 USD - 157,232.00 USD
    $91k-117k yearly est. Auto-Apply 44d ago
  • Intelligence SME

    Booz Allen Hamilton 4.9company rating

    Fayetteville, NC job

    The Opportunity: As an expert in defense missions, your unique background inspires you to think bigger, push further, and ask questions others don't. We need your extensive industry knowledge and advisory skills to guide teams as they solve some of our clients' most complex problems and find solutions that keep our nation safe. As an Intelligence Subject Matter Expert (SME), you will bring your training, knowledge, and tactical experience and expertise delivering intelligence support to operations to work alongside the thought leaders in multi-domain, multi-effect, multi-player synthetic training environments. You will join a team dedicated to the comprehensive integration of multi-domain platforms and capabilities into synthetic training events that stress the warfighter against real-world missions and the hardest problem sets. As a member of the team, you will leverage your knowledge and experience across a wide range of delivery mechanisms that include scenario and training event creation and execution, academic delivery, weekly skill facilitation, and real-world rehearsal support. Your skills will be vital in expanding intelligence integration across platforms and systems. Join us. The world can't wait. You Have: 3+ years of experience as a trained and deployed ITC within the special operations community 3+ years of experience as an intelligence professional within the special operations community, including HUMINT, IMINT, or SIGINT 3+ years of experience working in joint environments, Experience with School house as an intelligence instructor Experience with standard intelligence systems and tools Knowledge of the intelligence planning process and the national IC community Ability to work cooperatively and independently and provide academic or subject matter expertise instruction as necessary TS/SCI clearance HS diploma or GED Completion of an Intelligence Specialty Course Nice If You Have: Experience developing training exercises and scenarios Experience supporting multiple COCOMS, including EUCOM, PACOM, and SOUTHCOM Completion of any service exercise planning course Graduate of JPME I, PPME, or service equivalent Clearance: Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information; TS/SCI clearance is required. Compensation At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen's benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page. Salary at Booz Allen is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $86,800.00 to $198,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen's total compensation package for employees. This posting will close within 90 days from the Posting Date. Identity Statement As part of the application process, you are expected to be on camera during interviews and assessments. We reserve the right to take your picture to verify your identity and prevent fraud. Work Model Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely. If this position is listed as remote or hybrid, you'll periodically work from a Booz Allen or client site facility. If this position is listed as onsite, you'll work with colleagues and clients in person, as needed for the specific role. Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local, or international law.
    $86.8k-198k yearly Auto-Apply 4d ago
  • Specialist Manufacturing: NPI, Upstream Process Owner

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Specialist Manufacturing: NPI, Upstream Process Owner What you will do Let's do this. Let's change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC's biologics manufacturing facility and ownership of upstream unit operations. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations. New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet). Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence. Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion. Responds to regulatory questions and/or audit findings. Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Upstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications. Basic Qualifications: High school diploma / GED & 10 years of biotechnology operations experience OR Associate's degree & 8 years of biotechnology operations experience OR Bachelor's degree and 4 years of biotechnology operations experience OR Master's degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR Doctorate degree Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry Excellent cross-functional project management, meeting facilitation, and technical writing skills Experience in Upstream GMP manufacturing operations Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing. Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc. Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Ability to coach, mentor and/or cross train colleagues within core technical areas What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 112,977.00 USD - 139,179.00 USD
    $60k-82k yearly est. Auto-Apply 49d ago
  • Process Development Associate (Attribute Sciences)

    Amgen 4.8company rating

    Holly Springs, NC job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Process Development Associate (Attribute Sciences)** **What you will do** Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. + Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing. + Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements + Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing + Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR. + Execute methods, author reports and ensure safety and compliance for all activities. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. **Basic Qualifications:** + High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR + Associate's degree and 2 years of Process Development / Chemistry or related experience OR + Bachelor's degree **Preferred Qualifications:** + Degree in Chemistry or related area. + Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing. + Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR). + Experience in method transfers, method validation, and method troubleshooting. + Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation. + Effective oral and verbal communication skills. + Technical writing skills and attention to details in documents. + A self-starter and valuable teammate. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $68k-82k yearly est. 26d ago
  • Manager Manufacturing, Single Use Systems & Validation

    Amgen 4.8company rating

    Holly Springs, NC job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Manager Manufacturing, Single Use Systems & Validation** **What you will do** Let's do this. Let's change the world. In this vital role you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the- Manufacturing Support organization. ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. In this vital role, you will act as the Manager for Single Use Systems and Cleaning Validation, leading a team responsible for the oversight, implementation, and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations, process development, engineering, supply chain, and quality. + Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area. + Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation. + Lead development and execution of the site's Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies. + Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development. + Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility. + Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions. + Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections. + Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant. + Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies. + Develop and implement training plans and programs to ensure staff are prepared and compliant. + Maintain inspection readiness and support staff with audit or regulatory response strategy. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications. **Basic Qualifications:** + High school diploma/GED and 12 years of biotechnology operations or validation experience OR + Associate's degree and 10 years of biotechnology operations or validation experience OR + Bachelor's degree and 5 years of biotechnology operations or validation experience OR + Master's degree and 3 years of biotechnology operations or validation experience OR + Doctorate degree **Preferred Qualifications:** + Educational background in Chemical Engineering, Industrial Engineering, Biology, Biochemistry, Life Sciences, or related field. + Experience leading/managing a team of direct reports in a GMP manufacturing environment. + Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing. + Experience in supporting regulatory submissions, audits, and inspections. + Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff. + Experience in cross-functional project management and operational excellence initiatives. + Ability to coach, mentor, and cross-train colleagues within core technical areas. + Background in lean manufacturing methodologies and continuous improvement. + Knowledge of relevant regulations (e.g., FDA Title 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, ICH Q7). **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $92k-117k yearly est. 60d+ ago
  • Database developer

    Lockheed Martin 4.8company rating

    Fayetteville, NC job

    Database developer to support front end systems (as needed by developers across the organization, in support of web services, third party, or internal development needs) to the exclusion of reporting needs by other departments. Developed code includes but is not limited to PL/SQL in the form of Triggers, Procedures, Functions, & Materialized Views. Generates custom driven applications for intra-department use for business users in a rapid application development platform (primarily APEX). Responsible for functional testing and deployment of code through the development life cycle. Works with end-users to obtain business requirements. Responsible for developing, testing, improving, and maintaining new and existing processes to help users retrieve data effectively. Collaborates with administrators and business users to provide technical support and identify new requirements. Responsibilities Responsibilities: Design stable, reliable and effective database processes. Solve database usage issues and malfunctions. Gather user requirements and identify new features. Provide data management support to users. Ensure all database programs meet company and performance requirements. Research and suggest new database products, services, and protocols. Requirements and skills In-depth understanding of data management (e.g. permissions, security, and monitoring) Excellent analytical and organization skills An ability to understand front-end user requirements and a problem-solving attitude Excellent verbal and written communication skills Assumes responsibility for related duties as required or assigned. Stays informed regarding current computer technologies and relational database management systems with related business trends and developments. Consults with respective IT management in analyzing business functions and management needs and seeks new and more effective solutions. Seeks out new systems and software that reduces processing time and/or provides better information availability and decision-making capability. Job Type: Full-time Pay: From $115,000- 128,000 yearly Expected hours: 40 per week Benefits: Dental insurance Health insurance Paid time off Vision insurance Paid time off (PTO) Various health insurance options & wellness plans Required Knowledge Considerable knowledge of on-line and design of computer applications. Require Experience One to three years of database development/administration experience. Skills/Abilities Strong creative and analytical thinking skills. Well organized with strong project management skills. Good interpersonal and supervisory abilities. Ability to train and provide aid others.
    $115k-128k yearly 60d+ ago
  • Associate Scientist, Process Development (Process Validation & Business Strategy)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Scientist, Process Development (Process Validation & Business Strategy) What you will do Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgen's pipeline. The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen's pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed. Lead and develop the Process Development safety, training, and compliance monitoring operation Holistic Lab Execution Environment (HLEE) champion for the process development lab Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation Develop digital tools to support process validation and process monitoring activities Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process. Provide process floor or lab support as required What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications. Basic Qualifications: Bachelor's degree and 3 years of Process Development or Scientific experience OR Master's degree and 1 years of Process Development or Scientific experience Preferred Qualifications: 2 - 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role. Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes Familiarity in operational aspects of process development lab or commercial biopharma manufacturing Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements Excellent written and verbal communication Be a self-starter with the ability to take on several projects at one time. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 97,377.00 USD - 118,653.00 USD
    $57k-82k yearly est. Auto-Apply 2d ago
  • Principal or Senior Principal Network and Communications Field Service Engineer

    Northrop Grumman 4.7company rating

    Fayetteville, NC job

    At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advancements in our nation's history - from the first flight across the Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible. Our employees are not only part of history, they're making history. Northrop Grumman Aeronautics Systems is looking to add a **Principal or Senior Principal Network and Communications Field Service Engineer** to our team at **RAAF Base Edinburgh** near **Adelaide, Australia** . This position will receive daily tasking and prioritization from their site lead. The selected candidate will be responsible for operations and maintenance support of the MQ-4C Triton network and communications systems at a Forward Operating Base (FOB). **Duties and Responsibilities:** + Provide real time support for flight operations and maintenance, addressing any issues related to communications and networking to include fault isolation, remediation, and resolution. + Perform field integration, troubleshooting, and repair of communications and data link systems in military flight test environment, including operations on a flightline, in a hangar, and in command-and-control centers. + Adherence to checklists and procedures to ensure repeated success and providing redlines to procedures when necessary. + Communicate complex technical issues to local support, the Degrader Action Cell (DAC), Main Operation Bases (MOBs), and Responsible Engineers (REs). + Support and lead air crew engagement for proper techniques in solving complex analysis of technical problems that arise during operations. + Assist with trend analysis as needed for Responsible Engineers (REs). + Perform/support review and analysis of supplier design data and definition of functional test requirements including acceptance, qualification, and system integration. + Take responsibility for the testing, maintenance, and integration of Comms and Networks equipment to include radio terminals, software loads, switches, routers, and firewalls required to support ground and flight test operations. + Work with system admins, maintainers, and onsite personnel to troubleshoot and repair any internal operational issues. ** The selected candidate will be put on a temporary Domestic Assignment and will report to our San Diego, CA site daily prior to international deployment while clearance(s), Visa(s), and other documents are processing. The employee will go through training in San Diego during this period. ** **The expected timeline before deployment is 3-4 months but this will vary.** Initially, this position will work a 9/80 shift. **As the program matures, the shifts may become 12-hour shifts that could include nights, weekends, and/or holidays.** The selected candidate will be required to work full-time, on-site in Australia. This position requires the ability to **travel up to 50%** of the time once in final location. _This position can be filled at either the Principal Field Service Engineer OR Senior Principal Field Service Engineer level, depending upon the qualifications below._ **Basic Qualifications for Principal Field Service Engineer:** + Bachelor's Degree in a STEM (Science, Technology, Engineering or Mathematics) discipline and 5 years of related engineering experience; OR a Master's degree in a STEM discipline and 3 years of related engineering experience; OR a PhD in a STEM discipline and 1 year of related engineering experience. + Ability to obtain and maintain DoD 8140 approved IAT Level II (or higher) compliant certification. Examples include: Security+CE, CCNP, and CISSP. This certificate must be obtained within a reasonable amount of time as determined by the company to meet its business needs. + Competence in Linux, troubleshooting, engineering documents, tools and equipment + Familiarity with comms/networking operations + Ability to support assignment at location (RAAF Base Edinburgh in Australia) for minimum of 18 months + Ability to pass a new hire physical if determined necessary by Company, based on OCONUS location. + **Active** **DoD** **Top Secret** clearance (with a background investigation within the past 6 years or enrolled into Continuous Evaluation). + Ability to obtain and maintain SCI access. + Ability to obtain a CI Polygraph. + Ability to obtain and maintain Special Access Program (SAP) clearance. This SAP must be obtained within a reasonable amount of time as determined by the company to meet its business needs. **Basic Qualifications for Senior Principal Field Service Engineer:** + Bachelor's Degree in a STEM (Science, Technology, Engineering or Mathematics) discipline and 8 years of related engineering experience; OR a Master's degree in a STEM discipline and 6 years of related engineering experience; OR a PhD in a STEM discipline and 4 years of related engineering experience. + Ability to obtain and maintain DoD 8140 approved IAT Level II (or higher) compliant certification. Examples include: Security+CE, CCNP, and CISSP. This certificate must be obtained within a reasonable amount of time as determined by the company to meet its business needs. + Competence in Linux, troubleshooting, engineering documents, tools and equipment + Familiarity with comms/networking operations + Ability to support assignment at location (RAAF Base Edinburgh in Australia) for minimum of 18 months + Ability to pass a new hire physical if determined necessary by Company, based on OCONUS location. + **Active** **DoD** **Top Secret** clearance (with a background investigation within the past 6 years or enrolled into Continuous Evaluation). + Ability to obtain and maintain SCI access. + Ability to obtain a CI Polygraph. + Ability to obtain and maintain Special Access Program (SAP) clearance. This SAP must be obtained within a reasonable amount of time as determined by the company to meet its business needs. **Preferred Qualifications for both levels:** + Active DoD 8140 approved IAT Level II (or higher) compliant certification. Examples include: CCNA Security, Security+CE, CCNP, and CISSP + Technical expertise in all areas of network and computer hardware and software interconnection and interfacing, such as routers, firewalls, switches + Experience with test equipment: network analyzers, spectrum analyzers, signal generators + Cisco Certified Network Associate (CCNA) certification + Experience with communication technologies; examples include Internet Protocol (IP) networks, Voice over IP (VoIP), Information Assurance (IA), satellite and Line-of-Sight (LOS) RF communications, control interfaces, and co-site interference + Operations and Maintenance experience at a field site Primary Level Salary Range: $85,600.00 - $128,400.00 Secondary Level Salary Range: $106,800.00 - $160,200.00 The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions. Depending on the position, employees may be eligible for overtime, shift differential, and a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. The application period for the job is estimated to be 20 days from the job posting date. However, this timeline may be shortened or extended depending on business needs and the availability of qualified candidates. Northrop Grumman is an Equal Opportunity Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. For our complete EEO and pay transparency statement, please visit *********************************** U.S. Citizenship is required for all positions with a government clearance and certain other restricted positions.
    $106.8k-160.2k yearly 35d ago
  • Principal Air Vehicle System Test Conductor ( Various Int'l Locations)

    Northrop Grumman 4.7company rating

    Fayetteville, NC job

    At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advancements in our nation's history - from the first flight across the Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible. Our employees are not only part of history, they're making history. Northrop Grumman Aeronautics Systems has an opening for a **Principal Air Vehicle System Test Conductor- Engineering Field Service Representative (FSR)** to join our team of qualified, diverse individuals within our Test and Evaluation (T&E) organization. This position requires 6+ months of training on a Domestic Assignment to **Pax River, MD and Rancho Bernardo, CA.** After training is completed, it is expected that the candidate will be available to deploy to **Japan, Italy, United Arab Emirates, or Guam** for a minimum of **24 months** , based on current business needs. The international location will be selected by Northrop Grumman after training is completed and will be based on timing and available location(s), determined by business needs. Deployment benefits will be communicated once a location is selected. If no immediate international or Guam deployment location is available, the candidate may be relocated to work at one of our core U.S. locations for the immediate future. The FSR will be embedded with a US Navy unit and be the system subject matter expert, providing training on the system hardware and software, as well as supporting the sailors in the unit with system operations, troubleshooting, and routine maintenance. The Navy's intent is for sailors to be the primary operators and maintainers of the system, with the FSR providing training/assistance as needed to keep the system fully mission capable. The FSR will have reach-back/liaison support from Northrop Grumman Responsible Engineering/Development/Test Engineering teams. **Principal Test Conductor responsibilities include:** + Interfacing with NGC and customer Flight Engineers, aircraft maintenance Technicians, US Navy service members, and Subsystem SMEs in order to sustain operations. + Primary interface between maintenance, design and flight test engineering. + Vehicle and Payload Test Controller (VTC/PTC) operations during aircraft start-up/shut down for launch and recovery, conduct static ground tests, and troubleshooting. **Essential Functions:** + Responsible for providing inputs to update Interactive Electronic Technical Manuals (IETMS). + Reviews/provides inputs during engineering development and executes Detailed Test Requirements, Acceptance Test Procedures, and Ground Test Plans. + Installs, operates, troubleshoot, maintains, repairs, and modifies equipment, in accordance with IETMS and/or other engineering directives (TDs/ECRs/TEIs/AMRs/MAFs). + Perform a variety of Organizational / Depot-level maintenance and technical support on products such as equipment, integrated systems and subsystems, and software at customer and/or field locations. + Develop general knowledge of all aircraft systems, VTC/PTC, Engineering Design and software. Perform field integration, troubleshooting, and repair of air vehicle systems at the customer location including operations on a flightline, or in a hangar. + Ability to interpret and trace electrical and Air Vehicle schematics. Perform essential electrical and RF troubleshooting using equipment such as but not limited to: Multimeter, Network/Spectrum Analyzer, Oscilloscope, Time-Domain Reflectometer (TDR), etc. + Able to perform/support review and analysis of engineering schematics, supplier design data, support of functional test requirements including acceptance, qualification, and system integration on the Air Vehicle. **Basic Qualifications:** + Principal Test Conductor must have 9 years of related professional/military experience OR Bachelor's degree and 5 years of related professional / military experience, OR a Master's degree and 3 years of related professional / military experience + Willingness and ability to successfully complete required training in Pax River, MD and Rancho Bernardo, CA. + Willingness and ability to support an international assignment in Japan, Italy, United Arab Emirates, or Guam for a minimum of 24 months. The location will be selected by the Company and the selection will be based solely on business needs. + Willingness and ability to relocate to a core U.S. location, if necessary, based on business needs. + Ability to pass a new hire physical if determined necessary by Company, based on international location selected. + Must have a DoD Secret clearance that is in-scope or currently enrolled in CE, with the ability to obtain a Top-Secret/SCI clearance within a reasonable amount of time to meet business needs + Ability to obtain and maintain Special Program Access (PAR) within a reasonable amount of time for business needs + Experience with Aircraft Ground Test Operations + Possess the capability and readiness to travel, effectively supporting customer needs, management reviews, and demonstrating leadership as a technical expert on support trips worldwide. + Must have working knowledge of MS Office (Word, Excel & PowerPoint) and the ability to effectively communicate with various levels of leadership. + Strong interpersonal skills with excellent communications skills, including the ability to brief test results to senior leadership. **Preferred Qualifications:** + Ability to support a new and/or extended assignment at a company selected international or Guam location after the initial 24-month assignment. + Active DoD Top Secret clearance that is in-scope or currently enrolled in CE + Previous Unmanned Air Vehicle system test or maintenance experience is highly desired. MQ-4 Vehicle Test Controller or Triton BETTIE operator experience is preferred. + Aircraft Test or Lab Test experience is highly desired. + Experience with equipment to test and troubleshoot aircraft systems. + Experience with loading data and configuration files to aircraft assemblies Primary Level Salary Range: $91,200.00 - $136,800.00 The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions. Depending on the position, employees may be eligible for overtime, shift differential, and a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. The application period for the job is estimated to be 20 days from the job posting date. However, this timeline may be shortened or extended depending on business needs and the availability of qualified candidates. Northrop Grumman is an Equal Opportunity Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. For our complete EEO and pay transparency statement, please visit *********************************** U.S. Citizenship is required for all positions with a government clearance and certain other restricted positions.
    $91.2k-136.8k yearly 60d+ ago
  • Associate Director Technology

    Amgen 4.8company rating

    Holly Springs, NC job

    Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Associate Director Information Systems** **What you will do** Let's do this. Let's change the world. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide. + Responsible for providing and advancing manufacturing technology platform-specific implementation practices and standards on systems architecture, software libraries, and system lifecycle management in alignment with Operations Digital strategy and Industry 4.0 technology principles. + Manage Contract staff to deliver technology services using and improving the Global Solutions Delivery Model and Business Practice. The Capital portfolio spans across multiple functions; Process Development, Manufacturing Clinical & Supply Chain, and Commercial areas and includes a mix of facility expansions, systems upgrade and new construction projects. + Client executive relationship management responsibility with Amgen Corporate Engineering executives for Capital Projects as primary client, as well as site business executives as partners of the delivered systems and solutions. The candidate must be able to influence the development of business area strategy where appropriate. + Deliver the Drug Substance (DS) technology roadmap for Amgen and advance the digital maturity end to end throughout Amgen's Manufacturing network + Lead the execution of a varied portfolio of IS and Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio. + Shaping Amgen's future - Keep track of industry and technology trends, connect and cultivate external networking opportunities to deliver valuable insight from other similar professionals in our industry. + Effectively maintain relationships with IS service owners, business partners, enterprise IS service partners, and vendors + Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by utilizing technical, project management, and business expertise. + Performs cross system assessments, feasibility analysis, scope projects, prioritize projects, and provide efficient solutions. Manage multiple initiatives and priorities simultaneously. + Accountable to elicit and analyze needs identified by business customers and convert them into functional design. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of information Systems experience Or Master's degree and 4 years of Information Systems experience Or Bachelor's degree and 6 years of information Systems experience Or Associate's degree and 10 years of Information Systems experience Or High school diploma / GED and 12 years of Information Systems experience **Preferred Qualifications:** + 15 + years' experience providing process automation and information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries. + Candidates will have worked on process automation systems and completed projects of small to large sizes in cGMP regulated manufacturing environments, preferably both in Bulk API and Formulation/Fill/Finish facilities and will be knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations and understand software system validation. + Expertise on the following platforms: DeltaV, Werum, Systech, Laboratory systems, IS infrastructure and Industry 4.0 technologies + Exposure to sophisticated technologies around PAT, APC, AR/VR, Location tracking, Control tower, IIoT, IDA and so on would be an advantage. + Energetic, innovative and technically minded individual! + Demonstrate ability to lead and influence multi-functional teams and embrace a team-based culture. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen anticipates accepting applications until 10/07/2025; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $119k-152k yearly est. 60d+ ago
  • Senior Manufacturing Systems Engineer: Automation - DeltaV

    Amgen 4.8company rating

    Holly Springs, NC job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Senior Manufacturing Systems Engineer: Automation - DeltaV** **What you will do** Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust **process automation systems** to operate the new plant. **Site design, construction, start-up, and operational readiness** + Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems + Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements + Support vendor FAT to ensure that control strategy and software code meet Amgen requirements + Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes + Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy + Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO) + Support QA partners in performing computerized systems validation in a GxP environment + Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards **Site Operations** + Own and drive to completion Change Controls, CAPAs, and Deviations + Lead and support technical root cause analysis, incident investigations, and troubleshooting + Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility + Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability + Support day-to-day operations including rotational on-call support + Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications: **Basic Qualifications:** + High School diploma/GED and 10 years of engineering experience OR + Associate's degree and 8 years of engineering experience OR + Bachelor's degree and 4 years of engineering experience OR + Master's degree and 2 years of engineering experience OR + Doctorate degree **Preferred Qualifications:** + Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field + Direct knowledge of automation system design + Experience in programming, installation and lifecycle management of automation and field instrumentation technologies + Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep + Experience in integrating various OEM automation software + Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies. + Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies + Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95 + Self-directed team player able to work cross-functionally + Strong leadership, technical writing, and communication skills + Ability for domestic and international travel **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team!** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $77k-100k yearly est. 49d ago
  • Engineering, Project Manager

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Engineering - Project Manager What you will do Let's do this. Let's change the world. This role is responsible for the strategic planning, implementation, and oversight of complex, high-impact facilities projects. The individual will ensure that all initiatives are completed on schedule, within budget, and in alignment with organizational standards for safety, quality, and operational excellence. The position requires strong leadership, technical expertise, and the ability to drive multi-functional collaboration to deliver projects that support Amgen's mission to change the world through innovation and excellence. Lead and oversee the execution of multiple facilities engineering projects from initiation through completion, ensuring alignment with organizational goals and objectives. Develop comprehensive project plans, including scope definition, timelines, budgets, and resource allocation strategies. Coordinate and collaborate with internal stakeholders, external contractors, and consultants to ensure all project requirements, specifications, and deliverables are met. Provide leadership and direction to multi-functional project teams, encouraging accountability, technical excellence, and effective communication. Monitoring and evaluating project performance, identifying risks and implementing corrective actions to maintain schedule and budget adherence. Ensure all projects align with applicable regulatory requirements, industry codes, and company standards for safety and quality. Prepare, maintain, and present detailed project reports, status updates, and performance metrics to senior management and key collaborators. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The project management professional sought for this role will exemplify these values and possess the qualifications outlined below. Basic Qualifications: High school diploma / GED and 10 years of engineering project management experience OR Associate's degree and 8 years of engineering project management experience OR Bachelor's degree and 4 years of engineering project management experience OR Master's degree and 2 years of engineering project management experience OR Doctorate degree Preferred Qualifications: Demonstrated success in managing and delivering complex, large-scale projects within scope, schedule, and budget parameters. Leadership and team management capabilities, with the ability to empower and guide cross-functional teams toward successful outcomes. Exceptional communication, presentation, and interpersonal skills, with a focus on collaboration and stakeholder engagement. Strong ability to perform effectively under pressure, manage challenging priorities, and meet tight deadlines. Proficiency in project management methodologies, software, and analytical tools. Project Management Professional (PMP) certification or equivalent credential preferred. Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team!careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 122,112.00 USD - 147,362.00 USD
    $98k-123k yearly est. Auto-Apply 42d ago
  • Network Architect - Manufacturing

    Amgen 4.8company rating

    Holly Springs, NC job

    Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Specialist Network Engineer - Manufacturing** **What you will do** Let's do this. Let's change the world. In this vital role you will lead the design, implementation, and optimization of industrial IO and IoT network infrastructure across our manufacturing sites. This role is pivotal to advancing our Industry 4.0 strategy, enabling scalable, secure, and intelligent connectivity for smart devices, sensors, and edge platforms. **Key Responsibilities** + Architect and deploy robust IO and IoT network solutions for manufacturing environments, including edge-to-cloud integrations. + Collaborate with cross-functional teams (OT, IT, DevOps, Engineering) to define requirements and deliver scalable network solutions. + Develop and maintain documentation for network configurations, security policies, and deployment blueprints in line with Gartner's IoT Reference Model + Provide technical leadership in troubleshooting, risk mitigation, and continuous improvement of network operations. + Support IoT platform rollouts, including wireless sensor architecture and enterprise edge node deployments **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications. **Basic Qualifications:** Doctorate degree OR Master's degree and 2 years of Computer Science, Electrical Engineering, or related field experience Or Bachelor's degree and 4 years of Computer Science, Electrical Engineering, or related field experience Or Associate's degree and 8 years of Computer Science, Electrical Engineering, or related field experience Or High school diploma / GED and 10 years of Computer Science, Electrical Engineering, or related field experience **Preferred Qualifications:** + Strong expertise in industrial network architecture, standards governance, and multi-site rollout strategy. + Hands-on experience with Rockwell Stratix switches, Cisco IE platforms, and configuration tools such as Studio 5000, Cisco Industrial Network Director, or equivalents. + Proven ability to design and manage networks using PRP, DLR, and other redundancy and fault-tolerance protocols. + Deep understanding of routing, switching, VLANs, and segmentation in mixed OT/IT environments. + Familiarity with industrial protocols such as MQTT, OPC-UA, Modbus, and LoRaWAN. + Practical knowledge of industrial cybersecurity principles, including ISA/IEC 62443, network zoning, access control, and anomaly detection. + Experience in Layer 2/3 diagnostics, packet capture analysis, and bandwidth optimization within industrial networks. + Ability to work in high-performance cross-functional teams and manage vendor engagements across global sites. + Strong communication, collaboration, and documentation skills. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
    $95k-119k yearly est. 60d+ ago
  • Sr. Principal Air Vehicle System Test Engineer ( Various Int'l Locations)

    Northrop Grumman 4.7company rating

    Fayetteville, NC job

    At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advancements in our nation's history - from the first flight across the Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible. Our employees are not only part of history, they're making history. Northrop Grumman Aeronautics Systems has an opening for a **Air Vehicle System Test Engineer - Engineering Field Service Representative** (FSR) to join our team of qualified, diverse individuals within our Test and Evaluation (T&E) organization. This position requires 6+ months of training on a Domestic Assignment to **Pax River, MD and Rancho Bernardo, CA.** After training is completed, it is expected that the candidate will be available to deploy to **Japan, Italy, United Arab Emirates, or Guam** for a minimum of **24 months** , based on current business needs. The international location will be selected by Northrop Grumman after training is completed and will be based on timing and available location(s), determined by business needs. Deployment benefits will be communicated once a location is selected. If no immediate international or Guam deployment location is available, the candidate may be relocated to work at one of our core U.S. locations for the immediate future. The FSR will be embedded with a US Navy unit and be the system subject matter expert, providing training on the system hardware and software, as well as supporting the sailors in the unit with system operations, troubleshooting, and routine maintenance. The Navy's intent is for sailors to be the primary operators and maintainers of the system, with the FSR providing training/assistance as needed to keep the system fully mission capable. The FSR will have reach-back/liaison support from Northrop Grumman Responsible Engineering/Development/Test Engineering teams. **Sr. Principal System Test Engineer responsibilities include:** + Interfacing with NGC and customer Flight Engineers, aircraft maintenance Technicians, US Navy service members, and Subsystem SMEs in order to sustain operations. + Primary interface between maintenance, design and flight test engineering. + Vehicle and Payload Test Controller (VTC/PTC) operations during aircraft start-up/shut down for launch and recovery, conduct static ground tests, and troubleshooting. **Essential Functions:** + Responsible for providing inputs to update Interactive Electronic Technical Manuals (IETMS). + Reviews/provides inputs during engineering development and executes Detailed Test Requirements, Acceptance Test Procedures, and Ground Test Plans. + Installs, operates, troubleshoot, maintains, repairs, and modifies equipment, in accordance with IETMS and/or other engineering directives (TDs/ECRs/TEIs/AMRs/MAFs). + Perform a variety of Organizational / Depot-level maintenance and technical support on products such as equipment, integrated systems and subsystems, and software at customer and/or field locations. + Develop general knowledge of all aircraft systems, VTC/PTC, Engineering Design and software. Perform field integration, troubleshooting, and repair of air vehicle systems at the customer location including operations on a flightline, or in a hangar. + Ability to interpret and trace electrical and Air Vehicle schematics. Perform essential electrical and RF troubleshooting using equipment such as but not limited to: Multimeter, Network/Spectrum Analyzer, Oscilloscope, Time-Domain Reflectometer (TDR), etc. + Able to perform/support review and analysis of engineering schematics, supplier design data, support of functional test requirements including acceptance, qualification, and system integration on the Air Vehicle. **Basic Qualifications:** + Bachelor of Science Degree in Science, Technical, Engineering or Math (STEM) + A minimum of 8 years of engineering experience with a BS Degree, 6 years engineering experience with a MS degree in STEM Field, or 4 years with a PhD in STEM Field + Willingness and ability to successfully complete required training in Pax River, MD and Rancho Bernardo, CA. + Willingness and ability to support an international assignment in Japan, Italy, United Arab Emirates, or Guam for a minimum of 24 months. The location will be selected by the Company and the selection will be based solely on business needs. + Willingness and ability to relocate to a core U.S. location, if necessary, based on business needs. + Ability to pass a new hire physical if determined necessary by Company, based on international location selected. + Must have a DoD Secret clearance that is in-scope or currently enrolled in CE, with the ability to obtain a Top-Secret/SCI clearance within a reasonable amount of time to meet business needs + Ability to obtain and maintain Special Program Access (PAR) within a reasonable amount of time for business needs + Experience with Aircraft Ground Test Operations + Possess the capability and readiness to travel effectively supporting customer needs, management reviews, and demonstrating leadership as a technical expert on support trips worldwide. + Must have working knowledge of MS Office (Word, Excel & PowerPoint) and the ability to effectively communicate with various levels of leadership. + Strong interpersonal skills with excellent communications skills, including the ability to brief test results to senior leadership. **Preferred Qualifications:** + Ability to support a new and/or extended assignment at a company selected international or Guam location after the initial 24-month assignment. + Active DoD Top Secret clearance that is in-scope or currently enrolled in CE + Previous Unmanned Air Vehicle system test or maintenance experience is highly desired. MQ-4 Vehicle Test Controller or Triton BETTIE operator experience is preferred. + Aircraft Test or Lab Test experience is highly desired. + Experience with equipment to test and troubleshoot aircraft systems. + Experience with loading data and configuration files to aircraft assemblies. Primary Level Salary Range: $113,500.00 - $170,300.00 The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions. Depending on the position, employees may be eligible for overtime, shift differential, and a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. The application period for the job is estimated to be 20 days from the job posting date. However, this timeline may be shortened or extended depending on business needs and the availability of qualified candidates. Northrop Grumman is an Equal Opportunity Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. For our complete EEO and pay transparency statement, please visit *********************************** U.S. Citizenship is required for all positions with a government clearance and certain other restricted positions.
    $113.5k-170.3k yearly 60d+ ago
  • Senior Engineer, Process Development (Downstream)

    Amgen 4.8company rating

    Holly Springs, NC job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Senior Engineer, Process Development (Downstream)** **What you will do** Let's do this. Let's change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world. The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen's FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network. **Responsibilities include but are not limited to:** + Support technology transfer, process validation, and plant start-up + Provide technical leadership in **Downstream (Purification)** **Bioprocessing** for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management + Partner with cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives + Provide on-the-floor process support as required + Ensure safety and compliance of process development activities + Collaborate with other site-functions and network drug substance teams in delivering plant goals + Support regulatory filing, inspection, and other CMC activities **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications. **Basic Qualifications:** + High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR + Associate's degree and 8 years of biologics process development or commercial-scale technical support experience OR + Bachelor's degree and 4 years of biologics process development or commercial-scale technical support experience OR + Master's degree and 2 years of biologics process development or commercial-scale technical support experience OR + Doctorate degree **Preferred Qualifications:** + Master's degree in Engineering or Science discipline + 5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) + In-depth expertise in biologics process purification processes + Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation + Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders + Able to apply engineering principles and statistical analysis in resolving complex issues + Knowledge in regulatory filings and inspections + Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes + Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use) **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $88k-108k yearly est. 48d ago

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