Validation/ R&D Engineer

Mindlance; Fort Worth (TX); Presencial; USD 65 000 - 90 000; Tempo integral

Resumo da oferta

Mindlance is seeking a hands-on QA/Validation associate in Fort Worth, TX. The role focuses on equipment validation (IQ/OQ), data analysis, and documentation to support ophthalmic pharma product testing.

You will work with engineering to troubleshoot tests and ensure compliance with SOPs and regulatory requirements. The ideal candidate has 2+ years of related experience with a Bachelor's degree, or a higher degree with less experience.

Qualificações

• Bachelor's degree with 2+ years directly related experience, or higher degrees with less experience as noted.
• Fluency in reading/writing English.
• Ability to perform standardized tests per SOP and test methods.
• Capable of analyzing test results and summarizing findings clearly.
• Documentation of experiments and preparation of technical reports.

Responsabilidades

• Perform equipment validation (IQ/OQ) and related testing.
• Analyze data and maintain documentation aligned with quality requirements.
• Conduct root cause analysis and support investigations with engineering.
• Assist in designs and development of packaging or devices for ophthalmic pharma products.
• Document experiments in lab notebooks and draft protocols/reports.
• Draft and route standard operating procedures as required.
• Ensure compliance with QS requirements and timelines.

Conhecimentos

IQ/OQ testing

Data analysis

Problem solving

Lab documentation

Technical testing

Formação académica

Bachelor’s Degree or Equivalent

Ferramentas

Lab equipment operation

Descrição da oferta de emprego

o Equipment Validation Experience (IQ/OQ)

o Technical Documentation, Problem Solving and Root Cause Analysis

Schedule: 40 hours per week, Monday - Friday.

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 withs 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.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”