NovintiX
US - Massachusetts - Boston
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Company Description
NovintiX is a leader in engineering services, dedicated to innovating and transforming industries like Medical Devices, Aerospace, Automotive, Consumer Electronics, and Industrial Equipment. With cutting-edge expertise in areas such as Product Engineering, Digital Solutions, Supply Chain Management, and Quality Compliance, we empower meaningful solutions that drive growth and excellence. Guided by a forward-thinking vision, NovintiX fosters innovation while prioritizing the success of both clients and employees. Our mission to provide best-in-class services underscores a commitment to shaping a sustainable, technology-driven future.
Manufacturing Engineer
Role Overview
We are seeking experienced Manufacturing Engineers to support installation, commissioning, and qualification of new manufacturing equipment for a 3D Printing (3DP) production line launch within a MedTech/Pharma manufacturing environment. This is a fully onsite role requiring strong hands-on experience in equipment installation, commissioning, and validation (IQ/OQ/PQ).
Key Responsibilities
Support the installation, commissioning, and qualifications of new manufacturing equipment on-site
Author, review, and execute protocols and supporting validation documentation
Lead and execute activities required to transition equipment from installation through IQ. OQ, and PQ phase
Collaborate closely with Quality and Commissioning teams to ensure compliance with regulatory and internal standards
Perform hands-on equipment troubleshooting, testing, and qualification activities
Creation of controlled documentation (SOPs, work instructions, specifications)
Contribute to the successful startup of a new production line
Required Experience & Skills
5+ years of experience in validation within MedTech or Pharmaceutical environments
Strong experience with equipment validation and commissioning activities
Proven experience in process validation (IQ/OQ/PQ execution)
Familiarity with GMP, FDA, and regulatory requirements
Experience working with manufacturing equipment (3DP experience is an advantage)
Hands-on experience installing, commissioning, and qualifying manufacturing equipment
Proven ability to generate and execute URS and Qualification documentation and protocols
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