Capa Engineer Jobs in Exton, PA (NOW HIRING)

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address emerging validation considerations for AI/ML-enabled systems and automation frameworks. If this sounds exciting, then this team may be the right fit for you!

Work you'll do

As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk, and Forensic team, you will be responsible for...

• 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

A successful candidate would possess these skills:

• 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

The Team

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Qualifications

Required:

• 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.

Preferred:

• 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

For individuals assigned and/or hired to work in a remote role, Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to a remote role and takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $95,000 to $145,000.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address emerging validation considerations for AI/ML-enabled systems and automation frameworks. If this sounds exciting, then this team may be the right fit for you!

Work you'll do

As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk, and Forensic team, you will be responsible for...

• 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

A successful candidate would possess these skills:

• 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

The Team

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Qualifications

Required:

• 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.

Preferred:

• 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

For individuals assigned and/or hired to work in a remote role, Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to a remote role and takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $95,000 to $145,000.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.