Validation Specialist

Exton, Pennsylvania
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Type: Contract-to-Hire

Category: Scientific & Clinical

Job ID: 183087

Date Posted: 12/30/2020


Title: Validation Specialist

Location: Exton, PA
 


General Responsibilities:

Validation is a service group to the Operational Departments of Manufacturing, Quality Control and Facilities. Validation includes oversight, leadership and management of the validation program, including process validation, facility and utility qualification, equipment qualification and computer systems validation.

 

Responsibilities:

  • Author/review technical protocols and final reports
  • Implement and track site equipment requalification program
  • Take the initiative to create and implement the site validation strategies
  • Develop systems to monitor and ensure validated state is maintained for key processes and systems
  • Remain knowledgeable and current on manufacturing processes, quality systems and relevant GMP related to validation
  • Maintain current knowledge of industry standards and regulatory expectations
  • Provide subject matter expertise for overall validation program during regulatory and partner inspections
  • Alert senior management to any validation issues related to GMP, product quality or patient safety
  • Support regulatory filings and interact with FDA or other regulators regarding validation topics
  • Identify gaps in systems and develop feasible plans for correction
  • Work to ensure compliance with internal policies and procedures, and industry guidance’s and regulations, such as 21 CFR Parts 11, 210 and 211, and 600

Requirements:

  • Minimum Bachelor of Science degree in a scientific discipline
  • Minimum two years in a similar role in the biologics or pharmaceutical industry a plus
  • Familiarity with Batch Records and controlled documentation
  • Experience in aseptic processing and mammalian cell culture production considered a plus
  • Excellent leadership, technical, management, problem solving and project management skills
  • Ability to comprehend technical information related to facilities, utilities, equipment, processes, computer validation, scientific approaches and regulatory expectations


Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


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