Aseptic Process Validation Engineer II

Title: Aseptic Process Validation Engineer II
Location: Ft Worth, TX
Duration: 12+ Months
Pay Range: $35/hr–$40/hr
Schedule: 40 hours per week, Monday–Friday.

Description: Top 3 Must-Haves:

• Hands-on Technical Testing Competency

• Equipment Validation Experience (IQ/OQ)

• Technical Documentation, Problem Solving and Root Cause Analysis

Years of Experience: 2+ years of directly related experience with a Bachelor’s degree, or 0 years of experience with a Master’s degree.

Job Description:

• Hands-on and Technical Testing Competency

  • Ability to perform standardized tests per SOP and test methods.

  • Understands protocols, data collection, and proper use of lab equipment.

  • Focused on accuracy, repeatability, and compliance.

  • Perform equipment validation (IQ/OQ, etc.).

  • Prior experience working with Client is strongly preferred.

• Data Analysis & Documentation

  • Capable of analyzing test results, identifying trends or failures, and summarizing findings clearly.

  • Writes structured test protocols, reports, and maintains documentation aligned with quality and regulatory requirements.

• Problem Solving & Root Cause Analysis

  • Can identify potential issues in performance and support investigations (e.g., basic CAPA input, troubleshooting test failures).

  • Collaborates with engineers to improve designs, performance, or test methods based on results.

• Supports in the designs and development of a wide variety of packaging and/or devices used for the protection, display, handling, and delivery of ophthalmic pharma products.

• Performs assigned tasks under general supervision in support of approved projects.

• Executes engineering studies, conducts testing and data analysis under direction of senior OH team members. Receives technical guidance from senior OH staff on the design of experiments.

• Applies general technical skills to complete assigned work and solves routine problems of limited scope.

• Thoroughly and clearly documents experiments in laboratory notebook and assists in preparation of technical documents.

• Drafts protocols and reports to document related activities.

• Drafts and routes standard operating procedures as required.

• Drives effective actions for compliance within the agreed timelines.

• Ensures continual quality system compliance by adherence to established and evolving QS requirements.

• Communicates and collaborates with colleagues and supervisors.

• General use, set-up, and upkeep of laboratory, including equipment/instrumentation.

Key Requirements / Minimum Qualifications:

• Bachelor’s Degree or Equivalent + 2 years of directly related experience (or high school +8 years; Associate’s +6 years; M.S. +0 years); Mechanical Engineering major is desired.

• The ability to fluently read, write, and communicate in English.

• Work efficiently and productively with other team members and external partners.

• Adheres to Client's guidelines for appropriate workplace behaviors and attitudes.

• Prior experience working with Client is strongly preferred.