Computer Systems Validation Engineer

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 simplewe put the clients interests first we dont stop until its 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 persons success is everyones success. We work diligently to accomplish team goals and live our core values :

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)

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

Bachelors 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)

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

Critical Competencies

Influence Strategy

Satisfy the Customer

Plan for Success

Pursue Execution

Tailor Communication

Build Partnerships

Influence Others

Develop Self and Others

#LI-MV1

$75000 - $106000 a year

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

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 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. 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.

Required Experience :

IC

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1