Aseptic Process Validation Engineer II

Job Title: Aseptic Process Validation Engineer II
Job Location- Fort Worth, TX
Duration- 12 Months

Top 3 Must Haves:

• Hands-on Technical Testing Competency
• Equipment Validation Experience (IQ/OQ)
• Technical Documentation, Problem Solving, and Root Cause Analysis

Schedule:

40 hours per week, Monday - Friday.

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 design 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 the 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 notebooks and assists in the preparation of technical documents.
• Drafts protocol 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 with 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 yrs; Assoc. 6yrs; M.S. 0 yrs), 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.