Equipment Validation Engineer

Equipment Validation Engineer

Woodstock Sterile Solutions

Woodstock, IL

9+ month contract (chance to go direct but no guarantees)

Role will be hybrid. Days in office / at home will depend on where things are at in the project. Currently they are in office most days to help validate new equipment.

Seeking a validation engineer with experience in sterile filling equipment, particularly blow-fill-seal machines, as well as data systems such as instrument control and fill-and-dispense systems.

Validation engineer to support both equipment (blow-fill-seal machines) and data systems projects. Can have one or the other type of experience. Both would be a plus.

Ideal candidate should have 5+ years of experience writing validation documents like URS, SRS, and qualification protocols. Degreed engineer is preferred but open to candidates with a strong background with no degree.

Should ideally have experience in the pharmaceutical/sterile manufacturing industry, particularly with blow-fill-seal equipment validation.

Position Overview:

This position is for a validation contractor that will be working on projects that will involve the deployment of machinery and data systems in a pharmaceutical regulated environment.

Deployments maybe for completely new technology unfamiliar to company or upgrades to existing equipment/systems. Position will report directly to a project manager but will be expected to work independently with other project teams members and departments. Contractor maybe on multiple project teams. Teams will be built with members from technical, quality, and end user department members.

Job Description:

• Develop validation documents as needed. Documents will include the following:

• User Requirement Specifications/Software Requirement Specifications
• Validation Master Plans
• Configuration Specifications
• Installation Qualifications, Operational Qualifications, Configuration Qualification and Performance Qualifications.
• Risk Assessments for Machinery and Data systems in relation to compliance to 21 CFR Part 11 compliance
• Trackability Matrices
• Assistance in the generation of Standard Operational Procedures for equipment validated.
• Factory Acceptance Tests
• Site Acceptance Tests

• Assist and lead execution of qualifications.

• Work with equipment service personnel during deployment and initial validation as necessary including SAT.

• Projects will range from machinery to data system projects including Blow fill Seal Machinery, Data systems (laboratory & manufacturing), and lab equipment.

• Lead validation aspect of projects and managing execution of qualifications with minimal supervision.

Education and Experience Requirement:

• Bachelor's in engineering, science or technology, other degrees maybe considered based on experience in pharmaceutical industry and experience with machinery/data systems.