Cagents16mo ago

USD 75000–106000/yr

Computer Systems Validation Engineer

United States·RockvilleFull Timemid

OtherQA & TestingValidation EngineerComputer Systems Validation Engineer

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Quick Summary

Overview

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…

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…

Technical Tools

project-management

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

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).