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From Home Computer System Validation Jobs in Maryland

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Baltimore, MD

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Rockville, MD

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

Workforce Genetics

CSV Engineer

Baltimore, MD · On-site

Implement Computer System Assurance (CSA) Methodologies: Lead the transition from traditional, documentation-heavy Computer System Validation (CSV) to a right-sized, risk-based CSA approach ...

4 Consulting Inc

Computer Systems Analysts

Columbia, MD · On-site

... from stakeholders and translate business needs into practical processes, procedures, system ... validation, reporting, workflow development, and system integration. * Lead or support complex ...

New

IT EXCEL LLC

Jr QA Tester

Mount Rainier, MD · On-site

$55K - $58K/yr

... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ...

IT EXCEL LLC

Jr QA Tester

Mount Rainier, MD · On-site

$55K - $58K/yr

... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ...

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All JobsComputer System Validation JobsFrom Home Computer System Validation JobsFrom Home Computer System Validation Jobs in Maryland

From Home Computer System Validation information

What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?

AspectFrom Home Computer System ValidationFrom Home Quality Assurance Specialist
CertificationsGxP validation, 21 CFR Part 11ISO 9001, QA certifications
Work EnvironmentPrimarily remote, focused on system testing and validationRemote or onsite, focused on process audits and compliance
Industry UsagePharmaceutical, biotech, healthcareManufacturing, software, healthcare
Job FocusEnsuring computer systems meet regulatory standardsEnsuring overall quality processes and compliance

From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

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From Home Computer System Validation jobs near you

Computer Systems Validation Engineer

Baltimore, MD • On-site

CAI
See more jobs at CAIexternal

Full-time

Medical, Life, PTO

Re-posted 17 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.