Validation Engineer I

CAREERS WITH AN IMPACT

Cirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems.

Cirtec Medical Lowell - provides innovative single and multi-layer thin-film circuits and components for medical devices and other critical applications.

Our Culture - Our team is dedicated to fostering growth, innovation, and collaboration. We consistently seek opportunities for improvement to enhance our ability to assist clients. If you embrace a growth mindset and find motivation in challenges, you likely a great fit for our team!

This position is based onsite in Lowell, MA.

A day as a Validation Engineer I at Cirtec Medical

As a Validation Engineer I at Cirtec Medical, you will play a vital role in ensuring the success of our site. Reporting directly to the Engineering Manager, you will contribute to the enhancement of manufacturing processes through the authoring, execution, analysis, and summarization of process validation activities. This role focuses on areas such as equipment installation, change management, and continuous lifecycle improvement.

Responsibilities may include the following and other duties may be assigned:

• You will provide technical input to validation activities
• You will Represent process validation during equipment installations
• You will Support process validation Quality Systems
• You will Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices

Must Have:

• Bachelor's in Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering, Chemistry, or related field.
• 0-2 years of related experience in equipment or process validations.
• Experience with troubleshooting / problem-solving and risk assessment / mitigation
• Demonstrate ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices.

Good to Have:

• Experience authoring and building process validation studies for commercial GMP manufacturing processes
• Knowledge of cGMP requirements for validation documentation.
• Ability to adapt to a changing environment and handle multiple priorities
• Experience working in a manufacturing environment with Contract Manufacturing preferred.

EEO STATEMENT Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

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 Cirtec’s 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, Health care 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.