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For your reference, we have included the original job posting below.
Validation Engineer
Job Number:
42442092
Company Name:
Amgen
Job Location:
Woburn, MA US
Job Categories:
Engineering & Architecture Information Technology
Validation Engineer
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 understand the principle of Validation and Engineering. 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). •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.
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 Master's degree
OR
Bachelor's degree and 2 years of directly related experience
OR
Associate's degree and 6 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience
Preferred Qualifications Minimum of a BS in Engineering or related technical discipline. •4+ 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.
