Validation Engineer

We have an opening for a Validation Engineer on 1st shift at our Port Washington, WI location.

The Validation Engineer has the primary responsibility to provide documented evidence through the developments and execution of protocols, the equipment, and processes used to manufacture regulated products, to meet all the FDA and Kleen Test Products regulatory requirements

We are looking for a candidate with 1-2 years of experience with packaging, equipment validation, or engineering technical writing. Requires an associate or bachelor’s degree with a strong emphasis in a natural science or engineering. Candidates must have mechanical aptitude and experience in a regulated industry is preferable. The ideal candidate will be an independent worker, self starter, detailed, and have demonstrated the ability to see and understand a process.

What can KTP do for you?

• Develop yourself - Opportunities for rapid growth and advancement.
• Stability - We've never had a lay off!
• Respect and teamwork - You are not just a number at KTP; join our team and let us prove it to you!
  

Essential Functions

• Communicate technical knowledge with peers and colleagues in other departments.
• Develop and execute installation, operation, and performance qualification protocols and summary reports for processing equipment, utilities, computerized systems, and laboratory equipment.
• Develop and execute product validation protocols.
• Develop and execute cleaning validations.
• Perform training.
• Write Standard Operating Procedures (SOP’s) / Work Instructions (Wis).
• Interface with customers.
• Must maintain good documentation practices.
• Communicate effectively with cross-functional groups to meet compliance requirements and release goals.
• Assist in the maintenance of the Validation Master Plan (VMP) and Cleaning Validation Master Plan (CVMP) schedules throughout the organization.
• Other duties as assigned by management.

Requirements

• Requires an associate or bachelor’s degree with a strong emphasis in a natural science or engineering.
• Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or 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.
• Strong project management skills.
• Familiar with regulatory and GMP requirements for pharmaceutical manufacturing operations.
• PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint) along with Google Suite and Microsoft Outlook, statistical analysis software, and contract management software.
• Proven ability to maintain confidentiality and discretion with information.

Benefits

Culture

• Safety is KTP's top priority - everyone should go home in the same condition they came to work
• KTP builds collaborative relationships that strengthen the overall work environment
• Opportunity for growth, development and advancement within each department, or across departments
• Fast-paced environment, constantly changing, and the days go by quickly!

Benefits

• Comprehensive medical insurance plan and prescription drug coverage
• Comprehensive dental insurance plan
• FREE Basic Life and AD&D Insurance (company-funded & voluntary options)
• Short and Long Term Disability coverage (FREE company-funded coverage & voluntary options)
• Voluntary Life & Disability Program Eligibility
• Optional Flexible Spending Accounts (medical & dependent care)
• Prescription safety glasses cost-sharing program
• FREE financial wellness counseling and tools
• Time off for preventive care doctor appointments
• 401(k) retirement plan with employer match
• Employee Assistance Program (FREE to employees and your families)
• Paid vacation time (earn more as your seniority grows!)
• Company-paid holidays
• Nicotine-cessation aid reimbursement
• Continuing education opportunities/ Tuition Reimbursement program
• Onsite annual Health Risk Assessments
• Gym membership discounts (at participating locations)
• Community involvement & volunteer opportunities
• AT&T and Verizon wireless discounts

More info at - https://sites.google.com/kleentest.com/welcome/why-kt