CAI
Are You Ready?
CAI is a 100% employee-owned 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
With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values:
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
$75,000 – $106,000 a year
CAI Benefits
Comprehensive Health Insurance coverage
24 days of Paid Time Off
ESOP/401K - 15% Company Contribution (US Only)
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).
#J-18808-Ljbffr
CAI is a 100% employee-owned 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
With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values:
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
$75,000 – $106,000 a year
CAI Benefits
Comprehensive Health Insurance coverage
24 days of Paid Time Off
ESOP/401K - 15% Company Contribution (US Only)
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).
#J-18808-Ljbffr