Senior Engineer, Combination Products – Process Engineering Position Available In Middlesex, Massachusetts

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feellike youre part of something bigger, its because you are. Ourshared missionto serve patients living with serious illnessesdrivesall that we do. Since 1980, weve helped pioneer the world ofbiotech in our fight against the worlds toughest diseases. With ourfocus on four therapeutic areas Oncology, Inflammation, GeneralMedicine, and Rare Disease we reach millions of patients each year.

As a member of the Amgen team, youll help make a lasting impact onthe lives of patients as we research, manufacture, and deliverinnovative medicines to help people live longer, fuller happierlives. Our award-winning culture is collaborative, innovative, andscience based. If you have a passion for challenges and theopportunities that lay within them, youll thrive as part of theAmgen team. Join us and transform the lives of patients whiletransforming your career. Senior Engineer What you will do Lets dothis. Lets change the world. In this vital role you will lead partof development, and lifecycle management of manufacturing processesfor drug delivery drug/device combination products. This includestechnical operations support for design control activities, devicemanufacturing, failure investigations, leading and assessing designchanges impact to manufacturing, developing test procedures,leading scale-up and global launch, and continuous improvement.

Responsibilities of this position may include: Lead processcharacterization of prefilled syringe delivery systems, includingpackaging, labeling, and accessories. Lead process improvements,conduct analytical failure analysis, and implement processsolutions. Author technical records and ensure they areappropriately maintained in the e.g. Device Master record(DMR)/Master Manufacturing Record (MMR) Author technical content inTech Transfer. Represent Process engineering within a largenetwork/matrix organization. Evaluate test methods, prototypedesigns, and optimize products and processes using DOE andstatistical techniques. Monitor project progress, identify risks,and implement mitigation strategies to ensure project landmarks andtimelines are met. Key player in fostering a collaborative andinnovative team environment to drive continuous improvement andoperational excellence. What we expect of you We are all different,yet we all use our unique contributions to serve patients. Theengineering professional we seek will possess these qualifications.

Basic Qualifications:

High school diploma / GED and 10 years ofEngineering and/or Operations experience; OR Associates degree and8 years of Engineering and/or Operations experience; Or Bachelorsdegree and 4 years of Engineering and/or Operations experience; OrMasters degree and 2 years of Engineering and/or Operationsexperience; Or Doctorate degree

Preferred Qualifications:

Bachelor’s degree in engineering or other science-related fieldwith 7 years of relevant work experience with 5 years of experiencein operations/manufacturing environment. Medical device industryexperience and regulated work environment experience. A backgroundin developing and commercialization of medical devices andknowledge of manufacturing processes. At a minimum familiar withthe following standards and regulations: Quality System Regulation21CFR820, Risk Management

ISO 14971, EU

Medical Device requirementsCouncil Directive 93/42/EEC. Strong understanding and experience indesign controls, failure investigation, initiating and bringingcomplex projects to conclusion. Excellent communication andtechnical writing skills. Ability to work independently and acrossfunctional teams. S trong inter-personal and communication skills,with the ability to effectively collaborate with diverse teams andpartners. Extensive knowledge of design controls and regulatoryrequirements for medical devices and combination products.

Background in Combination product manufacturing processes andknowledge of developing and commercializing medical devices.

Familiarity with standards and regulations such as Quality SystemRegulation 21CFR820, Risk Management ISO 14971, and EU MedicalDevice requirements Council Directive 93/42/EEC. Strongunderstanding and experience in process failure investigation andproject management. Preferably have technical flair and arefamiliar with technical drawings and construction. Demonstratedproficiency in project management. Preferably have Strongbackground in statistical analysis (experience with e.g. Minitab,JMP is an advantage) Preferably have experience with KistlerMaxymos monitoring systems. Strong problem-solving skills and theability to make sound technical decisions Ability to thrive in afast-paced, dynamic environment and manage multiple priorities.

What you can expect from us As we work to develop treatments thattake care of others, we also work to care for your professional andpersonal growth and well-being. From our competitive benefits toour collaborative culture, well support your journey every step ofthe way. The expected annual salary range for this role in the U.S.(excluding Puerto Rico) is posted. Actual salary will vary based onseveral 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, comprisingof health and welfare plans for staff and eligible dependents,financial plans with opportunities to save towards retirement orother goals, work/life balance, and career developmentopportunities that may include: A comprehensive employee benefitspackage, including a Retirement and Savings Plan with generouscompany contributions, group medical, dental and vision coverage,life and disability insurance, and flexible spending accounts Adiscretionary annual bonus program, or for field salesrepresentatives, a sales-based incentive plan Stock-based long-termincentives Award-winning time-off plans Flexible work models,including remote and hybrid work arrangements, where possible Applynow for a career that defies imagination Objects in your future arecloser than they appear. Join us. careers.amgen.com In anymaterials you submit, you may redact or remove age-identifyinginformation such as age, date of birth, or dates of schoolattendance or graduation. You will not be penalized for redactingor removing this information. Application deadline Amgen does nothave an application deadline for this position; we will continueaccepting applications until we receive a sufficient number orselect a candidate for the position. As an organization dedicatedto improving the quality of life for people around the world, Amgenfosters an inclusive environment of diverse, ethical, committed andhighly accomplished people who respect each other and live theAmgen values to continue advancing science to serve patients.

Together, we compete in the fight against serious disease. Amgen isan Equal Opportunity employer and will consider all qualifiedapplicants for employment without regard to race, color, religion,sex, sexual orientation, gender identity, national origin,protected veteran status, disability status, or any other basisprotected by applicable law. We will ensure that individuals withdisabilities are provided reasonable accommodation to participatein the job application or interview process, to perform essentialjob functions, and to receive other benefits and privileges ofemployment. Please contact us to request accommodation. Amgen is anEqual Opportunity employer and will consider you without regard toyour race, color, religion, sex, sexual orientation, genderidentity, national origin, protected veteran status, or disabilitystatus. We will ensure that individuals with disabilities areprovided reasonable accommodation to participate in the jobapplication or interview process, to perform essential jobfunctions, and to receive other benefits and privileges ofemployment. Please contact us to request accommodation.