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Validation Quality Engineer

2 months ago

Horsham, Pennsylvania, United States Medix™ Full time

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

Position Overview: The Quality Assurance Validation Specialist acts as the key expert for the development, execution, review, and approval of various equipment and processes essential to the quality systems, production environment, and laboratory settings within the company. The primary focus includes validation and compliance documentation related to equipment qualification, process validation, test method validation, and associated change controls to ensure adherence to current Good Manufacturing Practices (cGMP) in a medical device context.

Key Responsibilities:

  • Draft, review, execute, and approve technical documentation, plans, protocols, and reports. This encompasses Equipment Qualification, Process Validation, Test Method Validation, change controls, and Standard Operating Procedures (SOPs) for In Vitro Diagnostic (IVD) and Research Use Only (RUO) products. Experience in Computer System Validation is advantageous but not mandatory.
  • Facilitate equipment qualification and requalification for laboratory instruments/systems, processing equipment, temperature-controlled devices, etc.
  • Lead and engage in quality and process enhancement initiatives and projects.
  • Remain informed about updates to GMP regulations, including those from the FDA, EU, ISO, and other regulatory authorities, as well as guidance documents pertinent to validation.
  • Collaborate frequently with Laboratories, Manufacturing, Quality Control, and Facilities to provide expertise on equipment qualification and validation. Address any issues with the relevant personnel and report findings to senior management as required.
  • Handle routine tasks according to established procedures, with the ability to identify deviations from accepted practices.
  • Participate in and support specific safety and quality responsibilities for the department and site, including GMP, audits, and health and safety standards.
  • Work collaboratively across functions, primarily with Research & Development/Product Support, Industrial Operations, Quality Control, and Facilities.
  • Oversee and coordinate the involvement 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, particularly in support of validation and qualification tasks.
  • Support and actively participate in third-party audits and regulatory inspection processes.

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, specifically managing qualification and validation processes.