Cleaning Validation Engineer
Responsibilities:
- 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