EQUIPMENT VALIDATION ENGINEER in Woodstock, IL on W2 basis

Overview

On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)

Skills

Installation Qualifications
Operational Qualifications
Configuration Qualification
Performance Qualifications
Site Acceptance Tests
validation

Job Details

EQUIPMENT VALIDATION ENGINEER

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.

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 system

validations

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.