ABOUT THE COMPANY 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. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.
Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers? devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!
ABOUT THE ROLE Join Cirtec Medical as a Validation Engineer where you will write, implement, analyze results and summarize process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement . You will also develop and assess the following Quality System elements for process Validation including CAPAs and deviations. As the Validation Engineer, you will report directly to the Engineering Manager and work with members of the Quality Assurance, Manufacturing, and Engineering organizations to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.
HOW YOU WILL CONTRIBUTE
o You will provide technical input to validation activities
o You will Represent process validation during equipment installations
o You will Support process validation Quality Systems
o You will Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
o You will Participate in regulatory agency inspections for Process Validation
o Serve as one of the main points of contact in communication to customer who?s equipment and processes you will be validating.
o Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities.
o Bachelor's in Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering, Chemistry, Biochemistry, or related field with 3 or more years relevant experience.
o 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
o Experience authoring & building process validation studies for commercial GMP manufacturing processes i
o Experience with troubleshooting / problem-solving and risk assessment / mitigation
o Working knowledge of the science and technology for the major unit operations associated with manufacturing operations is considered a bonus.
WHAT WE OFFER
In return, we offer you:
o Training and career development, with onboarding programs for new employees and tuition assistance
o Financial security through competitive compensation, incentives, and retirement plans
o Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
o Paid time off
o 401(k) retirement savings with a company match
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
Email resume to: Marianne.Segool@MassHireLowellCC.com.
How To Apply
Email resume to: Marianne.Segool@MassHireLowellCC.com