Process Validation Engineer

Title : Process Validation Engineer

Location: Boston, MA
Employment Type: Contract W2
Duration: 12+ Months
Rate: $44-48/hr on W2

About the Role

We are seeking Validation Engineers at Associate through Senior levels to support a large-scale QMS remediation program within a regulated medical device environment. This role focuses on hands-on validation execution, documentation remediation, compliance gap closure, and audit readiness.

Responsibilities

• Execute and remediate validation activities, including IQ/OQ/PQ and process validation.

• Identify and close validation and compliance gaps.

• Author and remediate protocols, reports, and validation documentation.

• Support documentation remediation and inspection readiness.

• Partner with Quality, Manufacturing, and Engineering teams.

Required Qualifications

Senior Level: 5 10+ years of validation experience in medical device or other regulated industries, with strong IQ/OQ/PQ execution and authoring experience.

Associate Level: 3 5 years of experience in validation, quality, or manufacturing, with exposure to regulated environments and validation execution/documentation.

• Strong knowledge of 21 CFR Part 820 and ISO 13485.

• Experience with validation documentation and remediation.

• Strong attention to detail and documentation skills.

Preferred Qualifications

• FDA inspection, warning letter, or remediation experience.

• CSV / 21 CFR Part 11 exposure.

• High-volume validation documentation remediation experience.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.