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- Compensation
- $95,000 – $145,000 USD
- City
- Arlington Heights, Atlanta, Austin, Baltimore, Birmingham, Boston, Charlotte, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Davenport, Dayton, Des Moines, Detroit, Fort Worth, Grand Rapids, Hartford, Hermitage, Houston, Huntsville, Indianapolis, Jacksonville, Jericho, Jersey City, Kansas City, Lake Mary, Louisville, McLean, Mechanicsburg, Memphis, Miami, Midland, Milwaukee, Minneapolis, Morristown, Nashville, New Orleans, New York, Philadelphia, Pittsburgh, Princeton, Raleigh, Richmond, Rochester, San Antonio, St. Louis, Stamford, Tallahassee, Tampa, Tulsa, Washington DC, Westlake, Williamsville
- Country
- United States
Currency: $ (USD)
Full Job Description
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System Test and Validation Lead
Arlington Heights, Illinois, United States
Arlington/Rosslyn, Virginia, United States
Atlanta, Georgia, United States
Austin, Texas, United States
Baltimore, Maryland, United States
Birmingham, Alabama, United States
Boston, Massachusetts, United States
Charlotte, North Carolina, United States
Chicago, Illinois, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dallas, Texas, United States
Davenport, Iowa, United States
Dayton, Ohio, United States
Des Moines, Iowa, United States
Detroit, Michigan, United States
Fort Worth, Texas, United States
Grand Rapids, Michigan, United States
Hartford, Connecticut, United States
Hermitage, Tennessee, United States
Houston, Texas, United States
Huntsville, Alabama, United States
Indianapolis, Indiana, United States
Jacksonville, Florida, United States
Jericho, New York, United States
Jersey City, New Jersey, United States
Kansas City, Missouri, United States
Lake Mary, Florida, United States
Louisville, Kentucky, United States
McLean, Virginia, United States
Mechanicsburg, Pennsylvania, United States
Memphis, Tennessee, United States
Miami, Florida, United States
Midland, Michigan, United States
Milwaukee, Wisconsin, United States
Minneapolis, Minnesota, United States
Morristown, New Jersey, United States
Nashville, Tennessee, United States
New Orleans, Louisiana, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Princeton, New Jersey, United States
Raleigh, North Carolina, United States
Richmond, Virginia, United States
Rochester, New York, United States
San Antonio, Texas, United States
St. Louis, Missouri, United States
Stamford, Connecticut, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Tulsa, Oklahoma, United States
Washington, District of Columbia, United States
Westlake, Texas, United States
Williamsville, New York, United States
Caution against fraudulent job offers. Learn more.
Position Summary
- Lead end-to-end validation activities for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
- Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, and data integrity expectations
- Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
- Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions
- Validate AI/ML-enabled GxP systems and automation testing frameworks, including development of validation approaches for non-deterministic outputs and documentation of AI governance requirements
- Ability to work independently and collaborate as part of a team
- Effective written and verbal communication skills
- Meticulous attention to detail and quality of work product
- Ability to build and sustain professional relationships
- Ability to lead projects or workstreams
- Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
- Strong interpersonal skills and professional demeanor
- Ability to meet deadlines
- Ability to provide clear guidance to others
- Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
- Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
- Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles
- Experience managing CAPA lifecycle activities and supporting inspection readiness for Food and Drug Administration or European Medicines Agency audits
- Experience validating AI/ML-enabled systems, distinguishing deterministic and probabilistic tool behavior, and qualifying or validating automation testing frameworks
- Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
- Limited immigration sponsorship may be available.
- Experience supporting periodic review programs for validated systems and associated CAPA triggers
- Experience validating cloud or software as a service platforms, including Veeva, ServiceNow, or Salesforce in a GxP environment
- Experience working in Agile delivery environments with validation activities embedded in sprints
- Experience with AI governance processes, including AI use case tracking, model risk classification, and disclosure requirements for GxP systems
From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters.
At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.
Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ways of thinking, ideas, and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work.
From entry-level employees to senior leaders, we believe theres always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.
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