Manufacturing Sciences and Technology Validation Manager

Company: Amgen
Location: West Greenwich
Posted on: January 12, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because 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, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.LiveWhat you will doLets do this! Lets change the world! In this vital role you will lead validation deliverables on a team responsible for cleaning, sterilization/sanitization, utility, airflow visualization, and benchtop testing equipment validation activities at AR5 and AR30 production facilities. Responsibilities will include validation program management. Responsibilities could potentially include management of direct reports.Key ResponsibilitiesBe an integral member of ARI validation leadershipValidation document author/approverRegulatory - validation oversight content authorshipPresent on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areasPrepare inspection playbooksValidation change control assessmentWrite/review RTQsAuthor applicable MA filing sectionsDrive Operational Excellence and Champion ChangeAuthorityDetermine outcome of validation activitiesDecision to approve or reject validation documentationProvide Validation position on related topics and strategy for the siteWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications:Doctorate degree ORMasters degree and 3 years of Manufacturing or Operations experience ORBachelors degree and 5 years of Manufacturing or Operations experience ORAssociates degree and 10 years of Manufacturing or Operations experience ORHigh school diploma / GED and 12 years of Manufacturing or Operations experiencePreferred Qualifications:10 + years biotech or pharmaceutical industry experienceSignificant Validation experience at Drug Substance Manufacturing facilitiesAble to facilitate and influence senior stakeholders and partnersAble to successfully manage workload and timelinesFamiliarity with basic project management toolsAbility to negotiate a strategic position after taking feedback from multiple sourcesStrong project management, problem-solving, and analytical skillsCollaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolutionAbility to operate in a matrixed or team environment with site, functional, and executive leadershipExperience driving decision making by using DAI principlesThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply now for a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com#Operations21Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, 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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Warwick , Manufacturing Sciences and Technology Validation Manager, IT / Software / Systems , West Greenwich, Rhode Island