Amgen Jobshttp://www.amgen.jobs2012-05-26 20:03:49.312008USAWoburnAuto req 15596BR Job Posting Title Sr Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - Massachusetts Location (City) Woburn Amgen Job Description Under general direction provide the coordination and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support manufacturing facilities. In addition the candidate will have to have an understanding of how the various pieces of manufacturing equipment operate, and experience in the field of Validation and Engineering. Self motivated individual who can function with minimal directions. Key Responsibilities: • Assist with the administrative and execution of Validation plans and validation protocols for major projects on site (facility, manufacturing processes, equipment, cleaning, and software). • Assist with the validation activities for the expansion project. • Prepare and /or revise validation protocols/procedures as required. • Review and execute qualification and summary reports, write and revise as needed. • Participate in review of manufacturing operational SOPs and maintenance for facility and process. • Assist in troubleshooting, complex or usual problems arising from equipment/system failures. • Ensure continuous validation maintenance for facility and process through change control program. • Analyze validation data, prepare reports, and make recommendations for changes and or/improvements. • Represent department in meetings when required. Other Responsibilities: • Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity. • Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. • Interface with manufacturing, technical operation and QC group. Basic Qualifications Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Educational Requirements: Minimum of a BS in Engineering or related technical discipline. Experience and Skill Requirements: • 6-8+ years experience in the validation of biotechnology or pharmaceutical equipment and processes. • Technical understanding of pharmaceutical/biotechnology unit operations. • Strong communication and interpersonal skills • Good knowledge of cGMP requirements and current industry practices • Demonstrate ability to work in a cross-functional team environment • The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.2012-05-09 20:34:40United StatesAmgenMassachusetts15596BRMAWoburn, MA28581296http://www.amgen.jobs/xml/28581296/jobUSACambridgeAuto req 15355BR Job Posting Title Scientist Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - Massachusetts Location (City) Cambridge Amgen Job Description Amgen is seeking a creative and highly-motivated Scientist to be part of a newly formed Therapeutic Innovation Unit at the Amgen Cambridge Research Center in Cambridge, MA. The Innovation Unit's mission is to carry out broad impact research projects that have the potential to significantly impact human disease outcomes. In this role you will use a strong background in molecular and cellular biology and have a working knowledge of genomic and bioinformatics tools. Additionally, you will use proven analytical and problem solving skills combined with the drive and scientific curiosity to successfully utilize the latest findings and technologies in our research programs. In this role you will work in a collaborative environment and on interdisciplinary teams. Basic Qualifications • Doctorate degree OR • Master’s degree & 6 years of scientific experience OR • Bachelor’s degree & 8 years of scientific experience Preferred Qualifications • A Ph.D. degree in the life sciences with 3-5 years of postgraduate research experience • A well-documented background of scientific expertise in molecular and cell biology. Experience in cell signaling and/or immunology is preferred • Experience with shRNA screening and Lentivirus experience is a plus • Ability to propose and implement scientific ideas consistent with the strategic needs of the Therapeutic Innovation Group • Excellent communication and interpersonal skills as well as the ability to function successfully in a matrixed team environment2012-04-25 21:10:36United StatesAmgenMassachusetts15355BRMACambridge, MA28183870http://www.amgen.jobs/xml/28183870/job