Validation Engineer

Phillips Medisize; Hudson (WI); Hybrid; USD 50,000 - 100,000; Full time

Job summary

A leading company in medical device manufacturing seeks a Validation Engineer for their Hudson, WI site. This hybrid position involves coordinating and leading validation projects to meet regulatory requirements and ensuring compliance across manufacturing processes. The ideal candidate will possess a Bachelor's degree in a scientific field and experience in quality assurance.

Benefits

Medical, dental, and vision insurance

Retirement plan

Paid vacation/time off

Qualifications

• Bachelor's Degree in a scientific discipline or 4+ years of direct Quality experience.
• 1+ years experience in a regulated manufacturing environment, preferably medical.

Responsibilities

• Lead validation projects and discussions.
• Execute computer system/software validation activities including risk assessments.
• Draft MVPs, equipment qualification, protocol/test cases.

Skills

Problem Solving

Organization

Education

Bachelor’s Degree in a scientific discipline

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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Your Job

Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. Our Global Technical Services Team is seeking a

Your Job

Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. Our Global Technical Services Team is seeking a Validation Engineer to support operations in our Hudson, WI site and other Wisconsin locations. This role will support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.

This is a hybrid position that can be based out of Hudson, New Richmond, or Menomonie depending on where the individual resides.

Our Team

Phillips-Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries. Our team at Hudson, WI is made up roughly of 300 employees that support our production, Engineering, Quality, Molding & Tooling departments.

What You Will Do

• Coordinate and lead validation projects and discussions.
• Work with project teams to define the validation strategy.
• Draft MVPs, equipment qualification, protocol/test case, deviations and summary report documentation for project wrap up.
• Execute computer system/software validation activities including risk assessments and part 11 compliance requirements
• Interface with customers to resolve issues and harmonize validation requirements.
• Learn and deploy SAP related tools and deliverables associated with validation documents and document approval workflows.
• Provide statistical analysis support to sites and validation teams.
• Assist with creating, updating, and training on WI, SOP, and other necessary documents needed to perform validation work.
• Support global rollout of Global Validation requirements and on-site or desk audits of Phillips-Medisize sites to ensure compliance to the global standards.
• Share validation best practices information and suggest improvement opportunities
• Travel to other Wisconsin Phillips Medisize sites (up to 50%) with occasional travel outside Wisconsin as needed.
  
  
  

Who You Are (Basic Qualifications)

• Bachelor’s Degree in a scientific discipline or 4 + years of direct Quality experience
• 1+ years experience working in a regulated manufacturing environment; medical manufacturing preferred
  
  
  

What Will Put You Ahead

• Strong organizational, and problem-solving skills and an understanding of quality system requirements
• Ability to identify problems, and develop and implement actions to resolve them
• Experience working with Microsoft Outlook, Word, Excel, and PowerPoint
• Project management experience
• Leadership/mentorship experience
• Working knowledge of medical device assembly and inspection equipment
  
  
  

This position does not qualify for VISA Sponsorship.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Hiring Philosophy

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here.

Who We Are

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Our Benefits

Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Equal Opportunities

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information. (For Illinois E-Verify information click here, aquí, or tu).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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