Computer System Validation Engineer

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY 

The CSV Engineer will interact with QA, IT, and business area users to generate user requirements and understand system functionality and use with respect to computerized systems and data integrity. Maintain current system functionality and use to ensure CGMP regulatory compliance. Perform periodic reviews and remediation activities for validated systems.

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

•    Possess strong knowledge of validation and related practices, including governmental regulations (e.g. 21CFR Part 11, EU Annex 11)
•    Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies
•    Subject matter expert on computer validation lifecycle process and ability to clearly articulate the process and systems at the plant to client and regulatory bodies
•    Validating/qualifying computerized manufacturing PLC-based and Windows-based systems operating in GXP environment and ensuring data integrity
•    Write and review computer system validation and data integrity documentation including:

• Validation Plans
• User Requirements
• IQ/OQ/PQ Protocols
• Part 11 Gap Analyses
• Trace Matrix
• Validation Summary Reports
• Periodic Reviews of computer systems
• Configuration specifications

•    Perform global computerized system risk assessments
•    Perform computerized system vendor evaluations
•    Represent Camden/MDCW on global project teams
•    Manage contractors assisting with CSV activities at Camden/MDCW
•    Represent CSV on data integrity teams
•    Act as a coach and mentor to other members of EFV and project teams to drive continuous improvement, knowledge transfer, and professional growth of self, as well as colleagues
•    Determines own instructions and procedures on day-to-day tasks and new assignments
•    Drive the complete execution of assigned projects in a manner that drives high engagement from project team members  

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. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

•    Bachelor's degree required  
•    The ideal candidate will have at least 7 years of experience in computer systems validation and 21 CFR Part 11 / Annex 11 in a GMP or GLP regulated industry.
•    Comprehensive knowledge and experience on computer validation lifecycle process.
•    Experience with SAP, PLCs and laboratory computer systems used in GMP and/or GLP environment
•    Basic skills and fluency in Microsoft Word, Outlook and Excel

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.