Quality Validation Engineer

Quality Validation Engineer Essential Duties and Responsibilities

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  Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility system
• sSchedules, plans, manages and executes studies for cleaning validation
• sSchedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocol
• sReviews and approves validation project documentatio
• nCoordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project execution
• sLeads and coordinates cross-functional teams for project validatio
• nPriorities, manages and executes multiple projects utilizing the project management methodologie
• sOversees external validation resource
• sSupports the development of best and proven validation practices in the validation department based on current industry guidelines and practice
• sAuthors relevant standard operating procedures for ensuring compliance with the company’s policie
• sSupports regulatory submissions and also regulatory agency inspections whenever requeste
• dChampions continuous improvements in the validation departmen

• )cGMP and Regulatory Compliance
  - Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organisatio
• nProfessional Communication
  - Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority level
• sComputer Literacy
  - Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based system
• sCollaboration
  - Utilize teamwork and problem solving skills across all departments and internally to Quality Assuranc
• eProject Management
  - The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manne

• eBachelor’s degree or higher in relevant scientific/technical fiel
• dTotal Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience preferre
• dExperience in project managemen
• tMust be well organized with a keen attention to detai
• lKnowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to tim