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Computer System Validation Manager Jobs in Rockville, MD

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

As a Computer System Analyst, you will analyze science, engineering, business, and other data ... Experience with OCONUS / Global Program Management and with DoD IT systems maintenance and ...

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Computer System Validation Manager information

See Rockville, MD salary details

$48.4K

$107.4K

$163.6K

How much do computer system validation manager jobs pay per year?

As of Aug 8, 2026, the average yearly pay for computer system validation manager in Rockville, MD is $107,448.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,900.00 and $134,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Rockville, MD? The most popular types of Computer System Validation jobs in Rockville, MD are:
What are popular job titles related to Computer System Validation Manager jobs in Rockville, MD? For Computer System Validation Manager jobs in Rockville, MD, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Rockville, MD look for? The top searched job categories for Computer System Validation Manager jobs in Rockville, MD are:
What cities near Rockville, MD are hiring for Computer System Validation Manager jobs? Cities near Rockville, MD with the most Computer System Validation Manager job openings:
Infographic showing various Computer System Validation Manager job openings in Rockville, MD as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 83% In-person, 6% Hybrid, and 11% Remote job distribution, with an average salary of $107,448 per year, or $51.7 per hour.

Computer Systems Validation Engineer

CAI

Rockville, MD

$75K - $106K/yr

Full-time

Re-posted 2 days ago


Job description

Are You Ready?
CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.
Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there.
 
Our Foundational Principles:
- We act with integrity
- We serve each other
- We serve society
- We work for our future
 
We work diligently to accomplish team goals and live our core values:
- Team Before Self
- Respect for Others
- Can-Do Attitude
 
This position could report to Rockville, MD or Frederick, MD
 
 
Key Responsibilities
Documentation & Compliance
Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
Generate and execute test protocols and scripts
Ensure adherence to 21 CFR Part 11 and data integrity principles
Review and contribute to validation plans and risk assessments
System & Industry Expertise
Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
Utilize familiarity with S88/S95 batch control standards
Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell
Client Support & Technical Execution
Support client engagements with strong customer-service orientation
Perform system assessments and remediation related to data integrity
Collaborate with client teams to ensure validation compliance and delivery
 
 
Qualifications and Experience
Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
Minimum of 3+ years of experience in computer systems validation
Experience in biotech or pharmaceutical environments preferred over medical device
In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
Familiarity with S88/S95 batch control standards
Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred
Experience with multiple automation and manufacturing execution systems is highly desirable
Data integrity assessment/remediation experience is a plus
 
 
Other Requirements
- Excellent oral and written communication skills in English
- Ability to travel domestically and internationally as required
- Willingness to work paid overtime when needed
- Must be authorized to work in the U.S. without current or future sponsorship
 
 
Critical Competencies
Influence Strategy
- Pursues opportunities based on organizational fit and strategy
- Identifies high-impact, innovative solutions
 
Satisfy the Customer
- Anticipates and meets client needs
- Delivers high-quality solutions and maintains satisfaction
 
Plan for Success
- Aligns business goals with execution plans
- Allocates resources and builds risk mitigation strategies
 
Pursue Execution
- Prioritizes effectively and ensures accountability
- Proactively addresses challenges
 
Tailor Communication
- Communicates clearly and professionally
- Adapts style for technical and non-technical audiences
 
Build Partnerships
- Builds cross-functional networks
- Promotes collaboration and stakeholder engagement
 
Influence Others
- Gains support through sound reasoning
- Promotes innovation and value
 
Develop Self and Others
- Demonstrates integrity and commitment to growth
- Builds effective relationships internally and externally
#LI-MV1
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
 
CAI Benefits:
•Comprehensive Health Insurance coverage
•24 days of Paid Time Off
•Company paid Life Insurance
•Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.
 
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.