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Validation Specialist II

Validation Specialist II

ID 
2017-1083
Category 
Quality Assurance
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The position is responsible for performing validation of utilities, equipment and processes to ensure compliance with GMP and GLP validation regulations. Key responsibilities include conducting all phases of the document process required for a successful validation program, annual review of system validation status, and execution of validation protocols. The incumbent is expected to work with direction to schedule validations with system owners and departments to meet the timelines. This position is key for the continued successful GMP manufacturing and GLP testing programs at MacroGenics, Inc.

 

Responsibilities and Job Duties:

  • Prepare Installation, Operation and Performance Qualification (IQ/OQ/PQ) protocols for new and in-use equipment and systems to ensure compliance with GMP and GLP validation regulations.
  • Perform validation of temperature controlled equipment, process equipment, utilities, and cleaning methods. 
  • Author validation plans and procedures required to ensure a robust validation program.
  • Assess system status to ensure systems remain in a validated state. 
  • Compile and analyze validation data, prepares reports and makes recommendations for changes and/or improvements.
  • Ensure that risk-based approach to qualification and validation to optimize system testing efforts is broadly applied. 
  • Other duties or special projects as assigned.

Qualifications

Education

 

Associate Degree in a scientific, technical or engineering discipline.

 

Experience

  • Three years of validation experience in biotech industry with a company in late phase 3 or commercial manufacturing.
  • Minimum of 3 years of experience in a GMP environment. 
  • Hands-on experience validating systems supporting GMP manufacturing (CTU’s, process equipment, utilities and cleaning methods).
  • Hands-on experience using Kaye Validator 2000 or similar systems.
  • Hands-on experience writing IQ/OQ/PQ protocols.
  • Hands-on experience writing validation final reports.
  • Experience evaluating system status to ensure the system remains in a validated state.

Knowledge, Skills and Abilities 

  • Be able to work in a team environment in a cooperative and respectful manner.
  • To interpret and apply regulatory knowledge to validation arena.
  • Be results driven with demonstrated successful outcomes.
  • Be able to handle multiple priorities in a fast-paced environment.
  • Possess excellent written and verbal communications skills. 
  • Exhibit excellent interpersonal skill and be able to interact with staff at all corporate levels to achieve the goals of the validation department.
  • Have attention to detail.
  • Be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).
  • Be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact.

Supervisory Responsibilities
No

 

Preferred Qualifications

  • Bachelor’s degree in scientific, technological or engineering discipline.
  • Experience writing validation master plans and standard operating procedures required for a robust validation program preferred.
  • Experience conducting FAT and SAT preferred. 
  • Prior experience supporting GLP validations. 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.