Associate Specialist II, Validation

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Job Summary

This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities, and computer systems utilized in the manufacture of products are validated for intended use.

The Associate Specialist II, Validation authors, reviews, coordinates, and executes qualification and validation documents, including process equipment, controlled environments, critical utilities, critical facilities, and decontamination / sterilisation of equipment.

Responsibilities  Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Responsible for process-related activities including the development of validation strategies, the estimation of validation timelines and resource requirements, the generation and approval of the project validation plans, the development of robust and efficient validation test protocols and reports for new and existing facilities, utilities, and equipment.
• Responsible for the coordination, communication, and completion of assigned validation tasks.
• Operate instrumentation to perform various environmental monitoring studies (temperature, relative humidity, etc.).
• Assist with reviewing User Requirements Specifications, Factory Acceptance Tests and Site Acceptance Tests for facilities, equipment, and utilities.
• Author documents such as procedures, summary reports, and status reports related to data integrity as required.
• Function as system administrator for defined computerized systems to maintain data integrity
• Working with cross functional teams in the development and execution of validation activities associated with new equipment, system and facility upgrades.
• Review and approval of documents prepared by the validation team, other departments, and contractor organizations as required.
• Resolving and assisting in the closure of deficiencies / deviations initiated during validation activities or as related to critical process parameters.
• Responsible for completing tasks driven by quality events such as Change Controls and Corrective Action Preventative Action (CAPA) plans.
• Assisting in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations.
• Participate in audit interviews and support audits, performed by regulatory agencies.

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills Requirements

There are physical / mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .