Equipment Validation Engineer – IQ/OQ | Medical Device
Job in
Bethel, Fairfield County, Connecticut, 06801, USA
Listed on 2026-06-25
Listing for:
JMD Technologies Inc.
Full Time
position Listed on 2026-06-25
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
Title:
Equipment Validation Engineer – IQ/OQ | Medical Device
Location:
Greater Bethel Area, CT (Onsite 5 days/week)
Employment Type:
Contract
Status:
Accepting Candidates
We are seeking an experienced Equipment Validation Engineer to support a large-scale manufacturing equipment transfer project within a regulated Medical Device environment. This role will focus on validating equipment relocated from another facility and ensuring compliance with quality and regulatory requirements.
Key Responsibilities- Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing equipment.
- Support validation activities for approximately 100 pieces of transferred equipment.
- Ensure compliance with ISO 9001 and ISO 13485 regulations and quality standards.
- Develop, review, and maintain validation documentation and reports.
- Collaborate with cross-functional teams during equipment relocation and qualification activities.
- Support equipment startup, troubleshooting, and readiness for manufacturing operations.
- Experience in Equipment Validation within a Medical Device or Biopharma manufacturing environment.
- Hands‑on experience performing IQ/OQ activities for manufacturing equipment.
- Strong knowledge of ISO 9001 and ISO 13485 requirements.
- Experience creating and executing validation protocols and documentation.
- Familiarity with equipment transfer, commissioning, or site relocation projects preferred.
- Experience with TMV (Transfer/Move Validation),
tube drawing
, or metal drawing processes is a plus.
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