What are the responsibilities and job description for the Validation Engineer II (Contract Opportunity) position at Cirtec Medical Corporation?
Please note - this is not a software validation role.
NO 3rd party candidates
Sponsorship is not available for this role
About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
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 challenges, 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. Will include developing and assessing following the 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 customers whose equipment and processes are being validated
- 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.
This is not a remote position
Must Have:
- Bachelors degree in Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering, Chemistry, Biochemistry, or related field with 3 or more years relevant experience
- Experience authoring and completing validation studies.
- Understanding of cGMP requirements for validation documentation.
- Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
- Experience authoring and building process validation studies for commercial GMP manufacturing processes
- Experience troubleshooting/problem-solving and risk assessment/mitigation
- Working knowledge of the science and technology for the major unit operations associated with manufacturing operation is considered a plus.
- Must be able to read, write and speak English
Cirtec Medical Corporation considers 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 of its related companies fully endorse equal opportunity for all. 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 Cirtecs goal to create a great 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 career and life stage. 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.
