Title: | Cleaning Validation Consultant |
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ID: | 1005 |
Location: | Dallas, TX |
Department: | Client Services |
Job Related Skills: | Biocompatibility, FDA Regulations |
job Description
Who are we?
Synergy Bioscience is a consulting services company providing its services to the FDA-regulated industries. As a consulting company, Synergy Bioscience is committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm, and diligence.
What we are looking for?
This is an immediate and exceptional opportunity to join our dynamic team of validation experts within their field. Synergy Bioscience is immediately seeking a Senior-Level Cleaning Validation Engineer. This is a highly visible role within our client organization. One in which a great deal of success will be determined by the Sr. Cleaning Validation Engineer’s ability to lead and execute our high-profile validation projects for one of the most prestigious Medical Device clients in the world.
To be considered for the position, you:
- Must have a proven track record of successful cleaning validation project execution
- Have strong experience with installation qualification (IQ) and operational qualification (OQ) related to IOQ equipment and support cleaning validation/ cleaning verification activities.
- Summarize and evaluate cleaning validation findings in a clear, orderly, and succinct manner
- Perform cleaning validation sampling using standard operating procedures (SOP)s to evaluate cleaning procedures
- Research and author Risk Assessments related to cleaning agents.
- Write cleaning validation/verification protocols, technical documents, IOQ protocols, and final reports
- Perform cleaning validation execution
- Experience with glass and parts washers, CIP skids, COP
- Experience with manufacturing equipment CIP cycles and cycle development
- Experience with CIP/COP of vessels, tanks, etc.
Qualifications
- 7 - 10 years of experience with cleaning validation in a regulated environment
- Working knowledge of ISO 10993, FDA and cGMP regulations, and documentation practices.
- Excellent written and verbal communication and technical writing skills.
- Proficient in Microsoft Office Suite and able to learn new computer applications.
- Must be results-oriented with hands-on experience with validation execution, familiar with industry concepts, practices, and procedures in a cGMP environment
If you are interested, please email your resume as MS Word attachment along with your expected hourly rate and two professional references for consideration.
Job Type: Contract
Pay: Based on experience.
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