Associate Validation Engineer

Sibitalent Corp; Danvers (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Sibitalent Corp is seeking an experienced Associate Validation Engineer to support a large-scale Medical Device Remediation Program in Danvers, MA. The role focuses on IQ/OQ/PQ, Process Validation, Equipment Qualification, TMV, and Inspection Validation within an FDA-regulated setting, working with Quality, Manufacturing, and Engineering teams.

Required are 5-8 years of Medical Device Validation experience, a Bachelor's in Electrical or Mechanical Engineering, and strong documentation skills.

Qualifications

• Experience with IQ/OQ/PQ, Process Validation, Equipment Qualification and TMV.
• Knowledge of FDA QMS & ISO standards.
• Strong technical documentation and reporting skills.

Responsibilities

• Execute IQ/OQ/PQ, Process Validation, Equipment Qualification and TMV.
• Perform Inspection Validation in FDA-regulated manufacturing.
• Collaborate with Quality, Manufacturing and Engineering teams to support remediation programs.

Skills

Medical Device Validation

IQ/OQ/PQ

Process Validation

Equipment Qualification

Test Method Validation

Inspection Validation

FDA Quality Systems

ISO Standards

Documentation & Reporting

Education

Bachelor's Degree in Electrical or Mechanical Engineering

Job description

Associate Validation Engineer (Electrical / Mechanical Focus)

Job ID:

629805

Location:

Danvers, MA (100% Onsite)

Duration:

Long-Term Contract (18+ Months)

Submission Requirements (Mandatory)

• LinkedIn Profile
• Photo ID (Driver's License or Passport)
• Two Manager References (No Co-workers)

Job Summary

Seeking an experienced Associate Validation Engineer to support a large-scale Medical Device Remediation Program. The role involves executing IQ/OQ/PQ, Process Validation, Equipment Qualification, Test Method Validation (TMV), and Inspection Validation within an FDA-regulated manufacturing environment while collaborating with Quality, Manufacturing, and Engineering teams.

Required Skills

• 5 8 years of Medical Device Validation experience
• Bachelor's Degree in Electrical or Mechanical Engineering
• Strong experience with:
• IQ/OQ/PQ
• Process Validation
• Equipment Qualification
• Test Method Validation (TMV)
• Inspection Method Validation
• Knowledge of FDA Quality Systems & ISO standards
• Excellent technical documentation and reporting skills

Preferred

• Electrical: Electronics manufacturing, soldering, inspection equipment validation
• Mechanical: Manufacturing process validation, assembly validation, soldering experience