Aseptic Process Validation Engineer II

Aseptic Process Validation Engineer II

📍 Fort Worth, TX (Onsite)

💰 Up to $58.00/hr W2 | 12-Month Contract with a likely extension

🏢 Client: a global medical device company

NO C2C or sponsorships

About the Role

Source One Technical Solutions is seeking an Aseptic Process Validation Engineer II to support a leading medical device organization in Fort Worth. This role is ideal for someone who thrives in hands-on testing, validation, and regulated environments, with a strong focus on accuracy, compliance, and data integrity.

You’ll play a key role in ensuring that critical systems, equipment, and processes meet strict quality and regulatory standards in a highly controlled environment.

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 Alcon is strongly preferred.
• Data Analysis & Documentation
• Capable of analyzing test results, identifying trends or failures, and summarizing findings clearly.
• Writes structured test protocol, 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 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 Alcon's guidelines for appropriate workplace behaviors and attitudes
• Prior experience working with Alcon is strongly preferred.
• Experience in medical device is preferred.
• Familiarity with statistical analysis and software is preferred