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Aseptic Process Validation Engineer II
Sunrise Systems Inc
- 🇺🇸 United States
- On-site
- 1 day ago
- CAPA
1 day ago
Not enough detail in this posting to match
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
Aseptic Process Validation Engineer II · Sunrise Systems Inc