Senior Validation Specialist

2 weeks ago


Houston, Texas, United States Unicon Pharma Inc Full time
Job Overview

Position: Senior Validation Engineer

Role Summary:

  • We are looking for an experienced Validation Engineer with a strong background in the pharmaceutical or medical device sectors. The ideal candidate should have at least 5 years of expertise in validating autoclaves (sterilizers), Purified Water Systems, and Pure Steam.
  • This position plays a crucial role in maintaining the compliance and operational efficiency of our equipment, thereby ensuring the quality and safety of our products.

Essential Qualifications:

  • Proficiency in statistical process control (SPC) and data evaluation.
  • Familiarity with steam sterilization technology and purified water systems.

Key Responsibilities:

  • Design, implement, and assess detailed validation protocols for sterilization equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Conduct comprehensive risk assessments to pinpoint potential risks associated with equipment and processes, and develop effective mitigation strategies.
  • Collaborate with various departments, including engineering, production, and quality assurance, to ensure smooth validation processes and adherence to compliance standards.
  • Prepare and maintain thorough validation documentation, including protocols, reports, and any deviations.
  • Investigate and address validation-related deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs) as necessary.
  • Stay informed about industry regulations and standards (e.g., FDA, EMA, GMP, ISO) to ensure ongoing compliance.
  • Provide technical guidance and support for inquiries related to autoclave and sterilizer operations.
  • Engage in continuous improvement initiatives aimed at enhancing validation processes and overall efficiency.

Desired Qualifications:

  • Bachelor's degree in Engineering, Science, or a related discipline.
  • A minimum of 5 years of experience in validating autoclaves and sterilizers within the pharmaceutical or medical device industry.
  • Extensive knowledge of autoclave and sterilizer 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 Dataloggers such as Kaye AVS and Ellab EValPro.
  • Strong understanding of validation methodologies and regulatory standards (FDA, EMA, GMP, ISO).
  • Excellent communication skills, both written and verbal.
  • Strong analytical and problem-solving capabilities.
  • Proficient in Microsoft Office Suite and validation software.
  • Able to work independently as well as collaboratively within a team.

Preferred Skills:

  • Experience with statistical process control (SPC) and data analysis.
  • Knowledge of additional steam sterilization equipment and purified water systems.
  • Certification in validation or quality assurance.


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