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Quality Assurance Validation Specialist

2 months ago

Horsham, Pennsylvania, United States Medix™ Full time

Medix™ is seeking a skilled Validation Quality Engineer to enhance our dynamic and expanding biotech organization. Candidates should possess substantial experience in equipment, method, and process validation.

Position Overview: The Quality Assurance Validation Specialist is the key expert responsible for the development, execution, review, and approval of various equipment and processes that are essential to the quality systems, production environment, and laboratory operations within the company. Key duties include ensuring compliance with validation and FDA-related documentation/protocols for equipment qualification, process validation, test method validation, and associated change controls to uphold cGMP standards in a medical device setting.

Key Responsibilities:

  • Draft, review, execute, and approve technical documentation, plans, protocols, and reports. This encompasses Equipment Qualification, Process Validation, Test Method Validation, related change controls, and SOPs for IVD and RUO products. Experience in Computer System Validation is advantageous but not mandatory.
  • Assist in the qualification and requalification of equipment: laboratory instruments/systems, processing machinery, temperature-controlled devices, etc.
  • Lead and engage in quality and process enhancement initiatives and projects.
  • Remain informed about updates to GMP, including FDA, EU, ISO, and other regulatory standards as well as guidance documents pertinent to validation.
  • Frequently collaborate with Laboratories, Manufacturing, QC, and Facilities to provide expertise on equipment qualification and validation. Address issues with relevant personnel and report findings to management as needed.
  • Perform routine tasks according to established procedures; demonstrate the ability to identify deviations from accepted practices.
  • Participate in and support specific safety and quality responsibilities for the department and site (i.e., GMP, Audits, Environment, and Health & Safety).
  • Work collaboratively across functions, primarily with R&D/Product Support, Industrial Operations, QC, and Facilities.
  • Oversee and coordinate the engagement of third parties for the installation and operational qualification of new equipment/instruments/systems.
  • Maintain the Validation Master Plan (VMP).
  • Engage in cross-functional design, development, and investigative activities (root cause analysis), particularly in support of validation and qualification efforts.
  • Support and actively participate in third-party audits and regulatory inspection activities.

Qualifications:

  • A Bachelor’s degree in a scientific or engineering discipline (Biomedical, Mechanical, Chemical Engineering, etc.), Biotechnology, Pharmaceutical Science, Quality Assurance, Manufacturing, or a related field is preferred.
  • A minimum of 3+ years of experience in a GMP, FDA, and ISO regulated environment.
  • Prior experience in quality engineering and managing qualification and validation processes.