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 companyNO C2C or sponsorshipsAbout the RoleSource 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 CompetencyAbility to perform standardized tests per SOP and test methods.Understands protocols, data collection, and proper use of lab equipment.Focused on accuracy, repeatability, and compliancePerform equipment validation (IQ/OQ, etc.)Prior experience working with Alcon is strongly preferred.Data Analysis & DocumentationCapable 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 requirementsProblem Solving & Root Cause AnalysisCan 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 projectsExecutes 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 activitiesDrafts and routes standard operating procedures as requiredDrives effective actions for compliance within the agreed timelinesEnsures 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/instrumentationKey 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 attitudesPrior experience working with Alcon is strongly preferred.Experience in medical device is preferred.Familiarity with statistical analysis and software is preferred