[{"country_short": "USA", "city": "Woburn", "description": "Auto req 15596BR\nJob Posting Title Sr Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Massachusetts\nLocation (City) Woburn\nAmgen 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.\nKey Responsibilities:\n\u2022 Assist with the administrative and execution of Validation plans and validation protocols for major projects on site (facility, manufacturing processes, equipment, cleaning, and software).\n\u2022 Assist with the validation activities for the expansion project.\n\u2022 Prepare and /or revise validation protocols/procedures as required.\n\u2022 Review and execute qualification and summary reports, write and revise as needed.\n\u2022 Participate in review of manufacturing operational SOPs and maintenance for facility and process.\n\u2022 Assist in troubleshooting, complex or usual problems arising from equipment/system failures.\n\u2022 Ensure continuous validation maintenance for facility and process through change control program.\n\u2022 Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.\n\u2022 Represent department in meetings when required.\n\nOther Responsibilities:\n\u2022 Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.\n\u2022 Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.\n\u2022 Interface with manufacturing, technical operation and QC group.\nBasic Qualifications Doctorate degree\n\nOR\n\nMaster\u2019s degree and 3 years of directly related experience\n\nOR\n\nBachelor\u2019s degree and 5 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications Educational Requirements: Minimum of a BS in Engineering or related technical discipline.\nExperience and Skill Requirements:\n\u2022 6-8+ years experience in the validation of biotechnology or pharmaceutical equipment and processes.\n\u2022 Technical understanding of pharmaceutical/biotechnology unit operations.\n\u2022 Strong communication and interpersonal skills\n\u2022 Good knowledge of cGMP requirements and current industry practices\n\u2022 Demonstrate ability to work in a cross-functional team environment\n\u2022 The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.", "date_new": "2012-05-09 20:34:40", "url": "http://www.amgen.jobs/xml/28581296/job", "country": "United States", "company": "Amgen", "title": "Sr Validation Engineer", "reqid": "15596BR", "state": "Massachusetts", "state_short": "MA", "location": "Woburn, MA", "uid": 28581296}, {"country_short": "USA", "city": "Cambridge", "description": "Auto req 15355BR\nJob Posting Title Scientist\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Massachusetts\nLocation (City) Cambridge\nAmgen 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.\n\nIn this role you will use a strong background in molecular and cellular biology and have a working knowledge of genomic and bioinformatics tools.\n\nAdditionally, 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.\n\nIn this role you will work in a collaborative environment and on interdisciplinary teams.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 6 years of scientific  experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications \u2022 A Ph.D. degree in the life sciences with 3-5 years of postgraduate research experience\n\n\u2022 A well-documented background of scientific expertise in molecular and cell biology. Experience in cell signaling and/or immunology is preferred\n\n\u2022 Experience with shRNA screening and Lentivirus experience is a plus\n\n\u2022 Ability to propose and implement scientific ideas consistent with the strategic needs of the Therapeutic Innovation Group\n\n\u2022 Excellent communication and interpersonal skills as well as the ability to function successfully in a matrixed team environment", "date_new": "2012-04-25 21:10:36", "url": "http://www.amgen.jobs/xml/28183870/job", "country": "United States", "company": "Amgen", "title": "Scientist", "reqid": "15355BR", "state": "Massachusetts", "state_short": "MA", "location": "Cambridge, MA", "uid": 28183870}]
