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Quality Assurance Validation Specialist

2 months ago

Houston, Texas, United States The Staffing Resource Group, Inc Full time

Validation Engineer

The Staffing Resource Group, Inc. provides tailored staffing solutions across the nation. We specialize in contract, contract-to-hire, direct hire, and executive search services. Our innovative approach allows us to efficiently identify and qualify talent, utilizing a state-of-the-art platform that enables precise matching of professionals to client needs. Our extensive database includes over one million candidates, ensuring continuous engagement with qualified talent.

  • Position: Validation Engineer
  • Location: Houston, TX
  • Industry: Pharmaceutical
  • Schedule: Monday to Friday, 8 AM to 5 PM
  • Compensation: Up to $68.94 per hour, paid weekly (benefits available; some pay flexibility possible)
  • Employment Type: 6-month contract
Company Overview: A leading global provider in the pharmaceutical, biotech, and specialty ingredients sectors, headquartered in Basel, Switzerland. The organization emphasizes advanced manufacturing, stringent quality control systems, regulatory expertise, and robust research and development capabilities. Their offerings include active pharmaceutical ingredients (API), stem cell therapies, water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives, and microbial control solutions.

Key Responsibilities:
  • Design, implement, and evaluate comprehensive validation protocols for sterilization equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Conduct detailed risk assessments to identify potential risks associated with equipment and processes, and develop effective mitigation strategies.
  • Collaborate with interdisciplinary teams, including engineering, production, and quality assurance, to ensure effective validation execution and adherence to compliance standards.
  • Prepare and maintain thorough validation documentation, including protocols, reports, and deviation records.
  • Investigate and address validation-related deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs) as necessary.
  • Stay informed on industry regulations and standards (e.g., FDA, EMA, GMP, ISO) to ensure compliance.
  • Provide technical support and expertise for inquiries related to sterilization equipment.
  • Engage in continuous improvement initiatives to enhance validation processes and operational efficiency.

Key Requirements:

  • Bachelor's degree in Engineering, Science, or a related discipline.
  • A minimum of 5 years of experience in validation of sterilization processes within the pharmaceutical or medical device sectors.
  • Extensive knowledge of sterilization principles, operations, and maintenance.
  • Experience with Control Systems (PLC, HMI, SCADA).
  • Familiarity with Computer System Validation.
  • Experience in qualifying purified water systems and pure steam generators.
  • Proficient in using temperature data loggers such as Kaye AVS and Ellab EValPro.
  • Strong understanding of validation methodologies and regulatory requirements (FDA, EMA, GMP, ISO).

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