Validation Engineer Job in Easton 21601, Maryland Us
Validation Engineer or Specialist wanted with cGMP experience.
We are a recruiting firm on a confidential search for a Validation specialist for a client located on Maryland’s Eastern Shore, in the heart of the Delmarva Peninsula. The salary range on this position depends on your experiences. There is some relocation assistance available for highly qualified candidates. If you are interested please forward your resume to:
Blair@HiringAuthorities.com
This position has some MANDATORY requirements. If you meet the below requirements, we should probably see your resume. If you do not have an updated resume, please email us what you have, with a one paragraph synopsis of what you have been doing since your last resume update
This is a time critical search, with an anticipated start date as soon as December.
- BS degree in chemistry, biology, engineering, or similar scientific field with 3 years experience or an Associate degree with 5 years experience in validation and or technical services experience in the pharmaceutical or medical device industry
- Analytical laboratory or method development experience
- Working knowledge of the operation, maintenance, and utility of all manufacturing equipment for assigned projects.
- Thorough familiarity with cGMPs, SOPs, and relevant government regulations
- Ability to identify potential cleaning issues, review and judge data, and provide suggestions for improvement
- Working knowledge of Microsoft Office applications.
- Ability to communicate effectively with individuals at all levels of the organization.
- Ability to write validation protocols and reports. Ability to track multiple projects
- Ability to prioritize multiple urgent tasks while performing daily duties
- Ability to identify cleaning process problems
- Ability to design and execute experiments to troubleshoot issues
We are looking for a Cleaning Validation Engineer in with experience in preparing and cleaning validation protocols, data analysis, and prepare cleaning validation summary reports.
Below is a sample job description that shows some of the key skills and requirements for a position of this nature. An actual job description will be given to highly qualified candidates that express interest
Typical Job Responsibilities
Write cleaning validation protocols using information gained from technical services, research and development, and published references, which clearly and robustly define the test functions to be executed.
Review and interpret analytical data. Evaluate cleaning process issues and determine performance trends, troubleshoot processes.
Assist in the preparation of various reports for FDA submissions.
Perform continual review of cleaning procedures in production to assure cleaning efficiency.
Coordinate all cleaning validation sampling with all affected departments. Prepare cleaning validation protocols, analyze data, and prepare cleaning validation summary reports. Perform cleaning validation sampling.
Coordinate all cleaning validation activities with the ultimate goal of minimizing equipment down time.
Monitor cleaning processes to ensure strict accordance with documentation.
Summarize and evaluate cleaning validation findings in a clear, orderly, and succinct manner.
Perform cleaning validation sampling, using standard operating procedures, to evaluate cleaning procedures.
Provide project team support.
Coordinate routine validation activities, such as SOPs, Safety and Training.
Develop and maintain schedules for assigned projects. Issue protocols, conduct the associated activities, and prepare the final reports.
Write and revise SOPs as deemed appropriate.
Review the weekly production and packaging schedules to verify that all cleaning validation activities are correctly reflected.
Communicate cleaning validation events to all affected departments, including Operations, Quality Control, and Production Planning.
Maintain all cleaning validation databases on a weekly basis to ensure that all requirements are correctly reflected and that all projects are tracked appropriately.
Organize all cleaning validation data and results such that needed information can be accessed quickly and easily.
Provide technical support to operations and contractors, as required. Lead project team using good organizational and communication skills, to provide production, RD, and technical services with properly cleaned equipment/facilities/systems for manufacturing/packaging.
Issue cleaning validation tags to operations for scheduled cleaning validation events.
Hiring Authorities, Inc., is a global recruiting firm specializing in the Medical Device, Pharmaceutical, Biotechnology, and related industries. We place multiple candidates each month at World Class companies. More information on us may be seen on our website or in MEDICAL DEVICE magazine.
These positions are all critical searches and all emails received will be answered if you are qualified.