Clinical and Scientific - Aseptic Process Validation Engineer

Job Title: Clinical and Scientific - Aseptic Process Validation Engineer
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
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.