What are the responsibilities and job description for the Validation Engineer position at Intellectt Inc?
Role: Validation Engineer
Location: Raynham, MA
Duration: 12 Months - Onsite (W2)
Job Description
- Minimum of 5 years in validation engineering.
- Prior experience in medical devices or other highly regulated industries is preferred. Candidates without this background will require extensive training.
- Strong proficiency in conducting non-conformance investigations and maintaining non-conformance records. Exceptional investigation skills are essential.
- Ability to handle a high volume of investigations efficiently. Training will be provided, but candidates should be comfortable managing multiple investigations simultaneously.
- Extensive experience with Test Method Validation (TMV) is highly desirable.
- Must be a self-starter with the ability to work independently while actively collaborating with colleagues.
- Experience supporting Corrective and Preventive Actions (CAPA), including APS and AMS.
- Familiarity with change control processes, including expertise in PLM systems, document redlining, and obtaining necessary approvals.
