Cleaning Validation Engineer

We are a privately-held manufacturer located and operated in Mooresville, North Carolina. We area a known industry-wide as a leading developer and marketer of innovative, consumer health care products for retailers and marketers of OTC drug products and dietary supplements. Specializing in manufacturing solid dose lozenges, soft chews, and other confectionery-based delivery forms of consumer healthcare products for both private label and contract manufacturing partners.

We offer competitive wages in addition to a comprehensive benefits package including a 401(k) with company match.
We are authentic and respectful in our dealings with others. This inspires confidence and transparency while empowering others to be open about differing ideas. We put what’s best for the team first. That means we take responsibility for everything we do – including our behaviors and our results

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

Supervisory Responsibility:
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.

Knowledge and Skill Requirements:
 Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation
documents, IOQ protocols and final reports