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Validation Engineer 2
Location:
Baltimore, MD
Description:
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed:to protect and enhance life. JOB SUMMARY Manage and prioritize all phases of assigned validation projects from concept through process validation and ongoing support of cGMP operations. They ensure cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures. Able to contribute at a high level in at least 2 of the following disciplines; Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. - Possesses strong knowledge of validation and related practices, including governmental regulations- Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies- Reviews and approve validation related system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols)- Perform hands on field work for equipment, aseptic processing, steam sterilization, cleaning validation, and process validation and their associated control systems- Uses proven monitoring and problem:solving techniques such as SPC and DMAIC- Provide customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader within the Validation department- Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents, and practices. These include but not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept risk- Act as a coach and mentor to other members of EFV and project teams to drive continuous improvement, knowledge transfer, and professional growth of self as well as colleagues- Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings. - Experienced professional with full understanding of work; resolves a wide range of issues in creative ways.- Work on problems of increasingly diverse scope; analysis of situation/data requires evaluation of identifiable factors.- Demonstrates good judgment in selecting methods and techniques for resolving issues and obtaining solutions.- Receives little instruction from supervisors, general instructions on new assignments.- Drive the complete execution of assigned projects in manner that drives high engagement from project team members. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. MINIMUM EDUCATION, EXPERIENCE, SKILLS Required - A minimum of 5 years of experience in a biopharmaceutical or related environment in the area of system qualification or validation- BS in Engineering, Science, Project/Program Management- Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and compliance for these technologies- Ability to think and act both strategically and tactically- Highly effective verbal and written communicator at all levels of the organization- Demonstrated ability to effectively prioritize and coordinate activitie
Posted:
May 7 on Tip Top Job
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More About this Listing: Validation Engineer 2
Validation Engineer 2 is a Engineering Validation Engineer Job located in Baltimore MD. Find other listings like Validation Engineer 2 by searching Oodle for Engineering Validation Engineer Jobs.
Validation Engineer 2 is a Engineering Validation Engineer Job located in Baltimore MD. Find other listings like Validation Engineer 2 by searching Oodle for Engineering Validation Engineer Jobs.