Specialist I, Data Integrity


Baltimore, MD, US, 21230


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.


The Data Integrity Specialist will be responsible for assisting the Camden facility in determining systems that are impacted by data integrity requirements.  The position requires thorough understanding of data integrity and 21 CFR Part 11 requirements.  Role requires working with cross functional teams to identify computerized needs for new systems, upgrading systems and decommissioning to ensure proper equipment is used and compliant.  The position requires strong technical knowledge of computerized laboratory and enterprise systems, GAMP processes, and risk management. A good understanding of the computer system validation to the software development life cycle is necessary.


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

•    Project Manage data integrity activities and cross-functional team meetings.
•    Manage a master list of systems for data integrity assessments.
•    Supports efforts for conducting risk assessments (i.e., risk, rank, filter, questionnaires, etc.) to establish risk levels.
•    Coordinate and create data flow process models and system configuration documents for each system determined to have significant data integrity risk based upon results of the system risk assessment.
•    Author documents such as procedures, summary report, and status reports related to the data integrity project as required.
•    Plan, organize, and conduct regular meetings with sub-teams to ensure timely completion of data integrity deliverables.
•    Track project and deliverable status and provide require project and deliverable status updates to Quality Assurance management.
•    Provide input to overall data integrity project plan.
•    Function as system administrator for defined computerized systems

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 


•    Bachelor’s degree required; will consider a combination of education/training and relevant work experience with skills in computer system validation, GAMP, Data Integrity, and 21 CFR Part 11 in a GMP regulated industry.
•    Minimum 5 years related experience and 7 years in pharmaceutical industry with relevant understanding of laboratory operations.
•    Basic skills and fluency in Microsoft Word, Outlook, and Excel
•    Experience with laboratory instrumentation/equipment and control  systems used in GMP and/or GLP environment




Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

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.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

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 .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.


Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.


  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Nearest Major Market: Baltimore