Job title: Aseptic Process Validation Engineer II

Location: Fort Worth, TX (onsite)

Duration: 12 months

Job Description:

• Hands-on and Technical Testing Competency
o Ability to perform standardized tests per SOP and test methods.
o Understands protocols, data collection, and proper use of lab equipment.
o Focused on accuracy, repeatability, and compliance
o Perform equipment validation (IQ/OQ, etc.)

• Data Analysis & Documentation
o Capable of analyzing test results, identifying trends or failures, and summarizing findings clearly.
o Writes structured test protocol, reports and maintains documentation aligned with quality and regulatory requirements

• Problem Solving & Root Cause Analysis
o Can identify potential issues in performance and support investigations (e.g., basic CAPA input, troubleshooting test failures).
o 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 device 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, conduct 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 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 supervisor.
• General use, set-up and upkeep of laboratory, including equipment/instrumentation


Key Requirements/ Minimum Qualifications:

• Bachelor’s Degree or Equivalent + 4 years of directly related experience (or high school +8 yrs; Assoc.+6yrs; M.S.+0 yrs)
• The ability fluently read, write and communicate in English.
• Work efficiently and productively with other team members and external partners.
• Adheres to guidelines for appropriate workplace behaviors and attitudes

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