CAI
Computer System Validation Engineer
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 client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our foundational principles are: 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: Team Before Self Respect for Others Can-Do Attitude Key Responsibilities: Documentation & Compliance System & Industry Expertise Client Support & Technical Execution 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 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 Satisfy the Customer Plan for Success Pursue Execution Tailor Communication Build Partnerships Influence Others Develop Self and Others $72,800 - $80,800 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. Benefits: Competitive compensation Up to 15% retirement contribution 24 days PTO + 5 sick days annually Low-cost health insurance for employees 70% long-term disability coverage paid by the company Financial support for internal/external education and certifications 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).
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 client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our foundational principles are: 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: Team Before Self Respect for Others Can-Do Attitude Key Responsibilities: Documentation & Compliance System & Industry Expertise Client Support & Technical Execution 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 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 Satisfy the Customer Plan for Success Pursue Execution Tailor Communication Build Partnerships Influence Others Develop Self and Others $72,800 - $80,800 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. Benefits: Competitive compensation Up to 15% retirement contribution 24 days PTO + 5 sick days annually Low-cost health insurance for employees 70% long-term disability coverage paid by the company Financial support for internal/external education and certifications 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).