For over 70 years, leading Fortune 500 companies have saved money and time by contracting with Kleen Test Products to discreetly manufacture and package their high-profile, consumer products. These well-known companies trust Kleen Test Products to maintain their solid reputation and satisfy their high expectations for superior quality and value.
LOCATION:
Headquartered in Port Washington, Wisconsin, Kleen Test Products has seven manufacturing and distribution facilities located in Wisconsin and Ohio.LOCATION:
PRIMARY FUNCTION:
State the primary function or overall purpose of your position.
The Validation Manager has the primary responsibility to oversee and coordinate all of Kleen Test Products’ validation work including, but not limited to, equipment, process, computer, utilities, method, cleaning, and sanitization.
ESSENTIAL FUNCTIONS: (Limit yourself to 8-12 statements)
List the essential functions (i.e. key responsibilities with expected end results), which must be accomplished in order to fulfill the purpose of your position as described above.
• Create, review, and approve protocols and final reports (IQ, OQ, and PQ)
• Write Standard Operating Procedures (SOPs)
• Develop and execute cleaning validations
• Maintain master validation plan
• Maintain cleaning validation master plan
• Perform temperature mapping and HVAC validations
• Review and approve change controls
• Facilitate the creation and review of policies and procedures as they relate to validation
• Facilitate training for sampling, testing, reporting, and data review in support of the validation
• Coordinate the completion of annual product reviews
• Participate in vendor acceptance testing
• Perform and/or provide support for vendor audits
• Coordinate relationships and contractual work with vendors and contractors
• Represent validation effectively with cross-functional groups to meet compliance requirements and release goals
SPECIALIZED KNOWLEDGE:
Describe any specialized knowledge or skill (e.g., technical, scientific, administrative, managerial), which your position requires.
• Requires an Bachelor’s degree with a strong emphasis in natural science; At least five (5) years of experience in validation and management
• Requires a thorough understanding of validation principles and quality philosophies in order to own and approve the validation quality system
• Understanding of Good Manufacturing Practices (GMPs)
• Requires the ability to read, analyze, and interpret business information, journals, technical procedures, and governmental regulations.
• Must have excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.
• Demonstrated excellence in project management
• Advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations, as well as the ability to apply such operations to tasks as frequency distribution, determination of test reliability and validity, analysis of variance, sampling theory and factor analysis.
• Proven ability to maintain confidentiality and discretion with information
• Exceptional organizational skills, along with strong attention to detail
• Excellent multi-tasking skills along with ability to perform well under pressure while maintaining composure and respect for everyone
• Demonstrated excellence in Microsoft Office (Word, Excel, Access, Power Point), as well as experience with Google Suite, statistical analysis software, contact management software, and the internet
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