Senior Associate ManufacturingManufacturing Investigations Employer Amgen Location Holly Springs, North Carolina Start date Jul 1, 2026 View more categories View less categories Discipline Clinical , Clinical Medicine , Manufacturing & Production Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.

Itstime for a career you can be proud of. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch 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 Associate Manufacturing Manufacturing Investigations Live What youwill do Letsdo this.

Letschange the world. In this vital role, you will be a key member of the team that investigatesmajordeviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams andstakeholder groupsincluding,Process Development,Facilities &Engineering,Automation, EHSS, andQuality. This positionis responsible forensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities include:

Managesimpledeviationand environmental monitoringinvestigations,specifically within theControlledEnvironmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings. Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations. Interpret environmental monitoring data,identifytrends, and assess potential impactstoproduct quality, manufacturing operations, and contamination control programs. Present investigations to regulatory inspectors, internal auditors, and management. Clearly communicate investigation progress toimpactedareas and leadership. Coordinate and effectively lead cross-functional teams through investigations, and complete milestones on-schedule. Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner.

Build effective relationships across functions. Navigate through ambiguity and provide a structured problem-solving approach. Apply inductive and deductive reasoning in the investigation process Clear and concise technical writing UseOperationalLearningTeam strategies topromote open collaboration with stafftomaximizeinvestigation findings. Developtracking tools to ensure on-time closure and proactivereviewof deviation investigations. Win What we expectofyou We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas a biologics Drug Substancemanufacturingandmicrobiologicalinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications :

HighSchoolDiploma/GED + 4yearsmanufacturing and/orotherregulatedenvironmentexperience Or AssociatesDegree+ 2 yearsmanufacturing and/orotherregulated environment experience Or BachelorsDegree+ 6 monthsmanufacturing and/orotherregulatedenvironmentexperience

Or Master'sDegree Preferred Qualifications:

3+ years related work experience (manufacturing,microbiology, process development,or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles. Experience with compliance, problem-solving,simple and complexroot cause analysistools (5-whys, fishboneetc.)critical thinking, project management, and quality systems. Degree in Science or Engineering(Microbiology or similar a plus) Experience leading investigations Experience usingVeevaQMSfor Deviation investigations and CAPAs Demonstrated project management ability Excellent written and verbal communication skills Ability to work in a team matrix environment and build relationships with partners Strong interpersonal skills Thrive What you can expectofus In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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 areprovidedreasonable accommodation toparticipatein 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. #AmgenNorthCarolina Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Automation Engineer II Clayton, NC Engineer 1 Thousand Oaks, California Application Engineer

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