Computer Systems Validation Engineer

CAI; Baltimore (MD); On-site; USD 75,000 - 106,000; Full time

Job summary

A leading company in the FDA-regulated industry is seeking a Computer Systems Validation Engineer in Baltimore. The role involves authoring GxP documentation, developing test protocols, and ensuring compliance with industry standards. Candidates should possess a BS in Computer Science or Engineering, with significant experience in validation processes. This position offers a competitive salary and comprehensive benefits, supporting professional development and work-life balance.

Benefits

Up to 15% retirement contribution

24 days PTO

5 sick days

Low-cost health insurance

Support for professional development

70% long-term disability paid by the company

Qualifications

• 3+ years experience with Computer Systems Validation.
• Experience with GAMP, 483, compliance, and deep knowledge of 21 CFR Parts 210, 211, and 11.
• Familiarity with S88/S95 batch control standard and Process Control Systems.

Responsibilities

• Write GxP computer validation and 21 CFR Part 11 related documentation.
• Develop and execute protocols and test scripts as required.
• Work on documents such as assessments, plans, URS, FRS, RTM, and summary reports.

Skills

Excellent oral and written communication skills

Ability to travel domestically and internationally

Education

BS in Computer Science or Engineering or equivalent experience

Tools

Rockwell PharmaSuite

Emerson Syncade

MES

Delta V

PI

GE

ABB

Werum

Siemens

Honeywell

PAS-X

FactoryTalk

PharmaSuite

FactoryLogix

PLM

Simatic

iFix

Wonderware

Job description

Position Description:

The Computer Systems Validation (CSV) Engineer is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. They will also develop and execute protocols and test scripts as required.

Requirements include:

Position Requirements:

BS in Computer Science or Engineering or equivalent experience

3+ years experience with Computer Systems Validation

Experience with GAMP, 483, compliance, and deep knowledge of 21 CFR Parts 210, 211, and 11 is preferred

Experience in biotech and pharma is preferred over medical devices

Experience with Rockwell PharmaSuite, Emerson Syncade, MES, Delta V, PI, and other major systems such as GE, ABB, Werum, Siemens, Honeywell, PAS-X, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc., is a plus

Familiarity with the S88/S95 batch control standard and Process Control Systems

Familiarity with Data Integrity assessment and/or remediation experience

Other Requirements:

Excellent oral and written communication skills in English

Ability to travel domestically and internationally as required

Able to work (paid) overtime

Able to work in the US without sponsorship now or in the future

About CAI

CAI is a 100% employee-owned company established in 1996 with over 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services for FDA-regulated and other mission-critical industries.

Are You Ready?

Our approach is to prioritize client interests, strive for excellence, and do whatever it takes to succeed.

As employee-owners, we are committed to our Foundational Principles: acting with integrity, serving each other and society, and working for our future. We value teamwork, respect, and a Can-Do attitude, which have contributed to our growth.

Benefits

Our full-time positions offer competitive compensation and benefits, including up to 15% retirement contribution, 24 days PTO, 5 sick days, low-cost health insurance, support for professional development, and 70% long-term disability paid by the company.

#LI-MV1

$75,000 - $106,000 per year

This is the average base salary range, excluding benefits, overtime, and Cost of Living Adjustments.

We are an equal opportunity employer, proud to employ veterans and promote diversity and inclusion. We are committed to fairness and equity for all employees, customers, and society.

This job description is not exhaustive; additional duties may be assigned. CAI considers qualified applicants with criminal histories in accordance with the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).