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 to support our Polymicro location in Phoenix, AZ and our Costa Mesa, CA facilities. We are open to candidates in either location, must be willing to travel up to 40% of the time between each location based on support needs.
Our Team
This role will manage, organize, and coordinate the activities of Validation Engineers with the goal of maximizing company profitability by providing products/services that meet customer expectations at the lowest cost. Support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.
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 Phillips-Medisize and vendor sites (up to 40%).
· Other duties as assigned
· Safety/Environmental: Where applicable, individual is pre-planning safety into work activities to improve performance, proactively identifies safety concerns, complies with Environmental Management System Program SOP’s/WI, Policy & Program elements and encourages responsible use of resources
Who You Are (Basic Qualifications)
- Bachelor’s Degree from an accredited college or university or 4 + years of direct Quality experience
- 1-year minimum 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 the project development process, associated terminology, and quality system requirements
- Excellent communication skills and the ability to effectively present information and respond to questions from group of managers, sales, and customers
- Ability to identify problems, and develop and implement actions to resolve them
- Competence with Microsoft Outlook, Word, Excel, and PowerPoint
- Good project management and Leadership skills, self-motivation
- Drive to complete projects on time every time
This position does not qualify for VISA Sponsorship
For this role, we anticipate paying $85,000 - $105,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.
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.
