Validation Engineer - Contractor

Job Description

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This is a temporary 6-month contracted 1099 position.

Position Overview:

We are seeking an experienced Validation Engineer to join our consulting team to support medical device clients in ensuring compliance with regulatory standards and internal quality systems. This role requires hands-on experience with validation lifecycle activities in a regulated environment, including equipment qualification, process validation, and cleaning validation. The consultant will work collaboratively with client teams to design, execute, and document validation protocols that meet FDA and international regulatory requirements.

Key Responsibilities:

Lead and execute validation projects including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Develop and write validation protocols, risk assessments, and final reports

Ensure validation activities comply with FDA 21 CFR Part 820, ISO 13485, and relevant GAMP guidance

Support equipment and process validation efforts related to manufacturing, packaging, and cleaning

Collaborate with Quality Assurance, Engineering, and Production teams to ensure validation documentation is accurate and complete

Participate in deviation investigations and support implementation of corrective and preventive actions (CAPA)

Provide technical guidance and validation expertise to clients during audits and inspections

Assist in developing or improving validation strategies and procedures for client systemsQualifications:

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Minimum of 5 years of experience in validation engineering within the medical device industry

Strong knowledge of FDA regulations, ISO 13485, and GxP principles

Experience with validation of manufacturing equipment, automated systems, and cleanroom environments

Proficient in writing and reviewing technical documentation

Strong problem-solving and communication skills

Ability to work independently or as part of a team in a client-facing role

Prior consulting experience a plusPreferred Skills:

Experience with computer system validation (CSV)

Familiarity with statistical tools and data analysis techniques

Knowledge of risk management tools such as FMEA and HACCP

Experience in both startup and mature manufacturing environmentsContract Details:

Competitive hourly rate based on experience

Duration and hours vary by project

Travel may be required depending on client site location#LI-RS1

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Full-time