The Cleaning Validation Engineer is responsible for the site's equipment cleaning validation program.
Essential Duties and Responsibilities:
Lead development and maintenance of cleaning validation program
Create cleaning cycle development strategies for a variety of equipment including: process vessels, clean-inplace systems, packaging equipment, parts washers, and production facilities.
Write validation protocols and reports in support of the site's validation program
Lead investigation and troubleshooting problems which occur during cleaning
Responsible for planning and execution of onsite cleaning validation programs compliant with US FDA
requirements.
Prepare and review completed and executed validation packages by compiling and analyzing validation data
for submittal for review and approval
Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies,
and manufacturing documentation review and approval
Develop and author change controls for cleaning process or equipment changes
Write and execute IQ/OQ/PQ/ and cycle development protocols including development of final reports.
Maintain an up-to-date knowledge of validation requirements, practices, and procedures
Write validation plans and risk assessments related to specific projects and facilities
Write and review policies and procedures (SOPs)
Facilitate the development of user requirement specifications and operational SOPs for equipment.
Perform risk assessment and gap analysis for site cleaning programs.
Lead cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
Lead continuous improvement activities related to cleaning and changeover optimization
Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing
effectiveness studies
Other duties as assigned
The Cleaning Validation Engineer may be responsible for coordinating the activities of two (2) or more team members.
The Cleaning Validation Engineer has the authority to correct process behaviors that violate department standards on the floor.
This job has no supervisory responsibilities.
Requirements:
2+ years of Cleaning Validation experience
Graduate degree in related field or 2+ years Cleaning Validation experience
Bachelor's degree in Engineering or Science
2+ years of Cleaning Validation experience in an FDA 21 CFR regulated industry
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