• Quality Assurance Validation Engineer

    Job Locations US-MD-Gaithersburg
    Job ID
    Compliance & Quality Assurance
    Posted Date
  • Overview

    Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge. 

    The Quality Assurance Validation Engineer (QAVE) is responsible for the development, implementation and administration for the equipment, software and process validation program to support the life cycle development and manufacture of ISO cGMP materials. This position ensures that all equipment, software and processes are assessed and an appropriate level of validation is determined through a risk assessment or other means and that the validation is completed and documented.  The QAVE identifies areas for improvement and actively participates on teams to evaluate and execute these needs; will establish and maintain a validation program for ATCC that comply with ISO and GMP standards.  

    This position must work and think independently; duties of this position are to be completed under minimal guidance. Discretion in handling assigned responsibilities, including the ability to resolve problems and exercise good judgment while maintaining confidentiality. Functions are to be completed in a timely manner with acceptable quality.


    1. Review and approve validation protocols prior to and after execution for accuracy/completeness; serves as a validation authority.
    2. Ensure that validation records are accurate and complete in accordance with standard operating procedures.
    3. Provide oversight of validation master plan and cleaning program.
    4. Analyze and interpret quality data from validation protocols to perform statistical analysis and determine process and/or equipment standard deviation criteria.
    5. Make determinations if equipment needs to be repaired or replaced.
    6. Develop standard operating procedures applicable to perform a risk assessment and develop the validation protocols that are needed to the applicable standard.
    7. Administer corrective and preventive action in accordance with standard operating procedures if a deviation is identified in the validation program.
    8. Manage and lead complex projects with a continued focus on compliance to applicable standards.
    9. Perform audits to applicable standards in an ISO and GMP environment.
    10. Understand the goals and objectives of ATCC, communicate, develop, motivate, and train staff toward the achievement of Quality goals.
    11. Make recommendations that align with enhancements to the current QA programs and implements as required to ensure compliance to the Quality Management System and encourages a continuous process improvement environment.



    Education and Experience:

    • A bachelor's degree in a life science field.
    • Minimum of five (5) years’ of QC and/or QA experience in a relevant manufacturing or related environment.


    Knowledge, Skills and Abilities:

    • Demonstrated understanding and experience working in a regulated environment, specifically cGMP.
    • ISO and GMP experience.
    • Ability to validate equipment in accordance with applicable regulations.
    • Self-starter, motivated and takes initiative; strong interpersonal and problem-solving skills; able to work collaboratively with all levels of staff to resolve problems to maximize performance, creativity, problem solving and results.
    • Seek, learn, and apply new skills/knowledge to perform job responsibilities.
    • Attentive to detail with a high level of accuracy; exercise sound judgment and strong project management skills.
    • Resourceful, diplomatic and professional; deliver outstanding customer service while managing relationships; a can-do attitude and work style that supports teamwork (and lead teams when necessary), collaboration and positive relationships.
    • Adaptable; be able to shift priorities and focus as departmental and/or business demands change.
    • Strong analytical skills and organized; completes tasks ahead of schedule.
    • Excellent written and verbal communication skills, including excellent listening skills and presentation skills to communicate clearly, concisely and effectively.
    • Position-relevant computer experience including Microsoft Office and procurement systems software.
    • Follow all company safety practices, Standard Operating Procedures (SOP’s) and policies. 


    Preferred Qualifications:

    • A Master’s degree.
    • Experience standing up a GMP processes or facility.      
    • Internal and external auditing experience.
    • Experience with ERP systems.

    ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.


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