Aseptic Process Validation Engineer II

Problem Solving & Root Cause Analysis o Can identify potential issues in performance and support investigations (e.g., basic CAPA input, troubleshooting test failures). " 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.

Job Title: R&D Engineer, Ocular Health Packaging & Device
Location: Fort Worth, TX 76134
Duration: 12+ months (with a possibility to extend).
Schedule: 40 hours per week, Monday - Friday.

Top 3 must haves:
oHands-on Technical Testing Competency
oEquipment Validation Experience (IQ/OQ)
oTechnical 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 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.) o Prior experience working with Alcon is strongly preferred.
" 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 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 fluently read, write and communicate in English.
" Work efficiently and productively with other team members and external partners.
" Adheres to Company's guidelines for appropriate workplace behaviors and attitudes
" Prior experience working with company is strongly

Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com