Validation Engineer I

*This is not a software validation Engineer position

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

Position Summary:

This position is responsible for writing, implementing, analyzing results, and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. Develop and assess the following Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.

Key Responsibilities:

• Provide technical input to validation activities
• Represent process validation during equipment installations
• Support process validation Quality Systems
• Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
• Participate in regulatory agency inspections for Process Validation
• Serve as one of the main points of contact in communication to customer whose equipment and processes you will be validating.
• Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities.
• Complies with company, quality, and safety standards, policies, and procedures * Other duties as assigned.
• This is not a remote position.

Must Have:

• Bachelor's Degree required with 1- 2 years of experience, or a combination of education and relevant work experience
• Experience authoring and completing validation studies. Understanding of cGMP requirements for validation documentation. Demonstrate ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
• Experience authorizing & building process validation studies for commercial GMP manufacturing processes.
• Experience with troubleshooting / problem-solving and risk assessment / mitigation
• Working knowledge of the science and technology for the major unit operations associated with manufacturing operations is considered a plus

Salary Range: $70,000-$87,000

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.