Gaithersburg, MD · On-site
$170K - $190K/yr
... system validation (CSV), and data integrity principles. · Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. · Excellent ...
Quick apply
Gaithersburg, MD · On-site
$170K - $190K/yr
... system validation (CSV), and data integrity principles. · Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. · Excellent ...
Gaithersburg, MD · On-site
... system validation (CSV), and data integrity principles. • Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. • Excellent ...
Gaithersburg, MD · On-site
... system validation (CSV), and data integrity principles. • Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. • Excellent ...
Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles. Experience leading automation system design ...
Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles. Experience leading automation system design ...
Max Rate $$.$$$.$$ Onsite Princeton NJ 1. hands-on experience in Computer System Validation as a Validation Analyst/Lead working experience in GxP systems. 2. Hands on Applications knowledge on GxP ...
Max Rate $$.$$$.$$ Onsite Princeton NJ 1. hands-on experience in Computer System Validation as a Validation Analyst/Lead working experience in GxP systems. 2. Hands on Applications knowledge on GxP ...
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
Gaithersburg, MD · On-site
$69 - $88.50/hr
Bachelor's degree in Computer Science, Computer Engineering, Mathematics, Information Science, or a ... Familiarity with GxP software validation, computerised system validation (CSV), or regulated ...
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Baltimore, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Baltimore, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS.
Senior Computer Systems Analyst Category: Infrastructure/Cloud Main location: United States ... Support development of coding, testing, debugging, and system validation requirements . Liaise with ...
Senior Computer Systems Analyst Category: Infrastructure/Cloud Main location: United States ... Support development of coding, testing, debugging, and system validation requirements . Liaise with ...
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Mount Rainier, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Mount Rainier, MD · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Rockville, MD · On-site
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Rockville, MD · On-site
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Rockville, MD · On-site
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Rockville, MD · On-site
$98K - $163K/yr
The electronic chemical inventory system is the central critical component to this process, and the ... Knowledge of software license management, upgrades, patches, and compatibility validation.
Formulate detailed system specifications for use by computer programmers ... Support development of coding, testing, debugging, and system validation requirements . Liaise with ...
Formulate detailed system specifications for use by computer programmers ... Support development of coding, testing, debugging, and system validation requirements . Liaise with ...
Baltimore, MD · On-site
$44.66 - $55.53/hr
Armed Forces military service experience as a commissioned officer in the Computer Systems ... One year of experience providing advanced Tier 3 technical support, system validation, or incident ...
Baltimore, MD · On-site
$44.66 - $55.53/hr
Armed Forces military service experience as a commissioned officer in the Computer Systems ... One year of experience providing advanced Tier 3 technical support, system validation, or incident ...
... computer systems, utilities, and/or facilities Strong technical writing and oral communication skills Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project ...
... computer systems, utilities, and/or facilities Strong technical writing and oral communication skills Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project ...
Baltimore, MD · On-site
$44.66 - $55.53/hr
... system outages,monitor production environments, and validate hotfixes.\r\n Conduct in-depth ... Candidates may substitute experience operating computer systems; or scheduling,controlling input ...
Baltimore, MD · On-site
$44.66 - $55.53/hr
... system outages,monitor production environments, and validate hotfixes.\r\n Conduct in-depth ... Candidates may substitute experience operating computer systems; or scheduling,controlling input ...
... computer systems, utilities, and/or facilities Strong technical writing and oral communication skills Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project ...
... computer systems, utilities, and/or facilities Strong technical writing and oral communication skills Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project ...
Columbia, MD · On-site
... computer systems, utilities, and/or facilities • Strong technical writing and oral communication skills • Proficiency with project documentation and computer skills (Microsoft Office, Microsoft ...
Columbia, MD · On-site
... computer systems, utilities, and/or facilities • Strong technical writing and oral communication skills • Proficiency with project documentation and computer skills (Microsoft Office, Microsoft ...
To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.
A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.
Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.
$170K - $190K/yr
Full-time
Posted 5 days ago
Catalyx is seeking an Automation Subject Matter Expert (SME) provides technical leadership for the design, implementation, validation, and lifecycle support of automation systems supporting biologics manufacturing operations. This role ensures automation solutions are reliable, compliant, secure, and aligned with industry standards while supporting upstream and downstream process performance. The SME works closely with engineering, manufacturing, quality, validation, and system integration teams to deliver scalable automation solutions throughout the project lifecycle.
Responsibilities
· Provide technical leadership for automation systems supporting biologics manufacturing, including upstream, downstream, buffer/media preparation, and clean utility systems.
· Develop and review automation architecture, control strategies, functional specifications, batch recipes, and system design documentation.
· Support automation deployment strategies, technology evaluations, and digital manufacturing initiatives, including data integration and operational optimization.
· Oversee system integration, commissioning, qualification, and validation activities, including FAT, SAT, IQ/OQ, and commissioning support.
· Ensure automation systems comply with GMP, GAMP 5, ISA-88, ISA-95, data integrity, cybersecurity, and other applicable regulatory standards.
· Collaborate with cross-functional teams to define process control requirements, batch reporting, system interfaces, and operational readiness.
· Support risk assessments, alarm management, cybersecurity, and automation lifecycle management.
· Provide technical guidance to vendors, system integrators, and internal engineering teams while promoting automation best practices and continuous improvement.
· Bachelor's or Master's degree in Automation, Electrical, Controls, Chemical, Process Engineering, or a related technical discipline.
· 8+ years of experience supporting automation systems in GMP biologics or pharmaceutical manufacturing environments.
· Strong experience with DCS, PLC, SCADA, ISA-88 batch systems, process historians, MES/LIMS integration, and industrial networking.
· Hands-on experience with biologics manufacturing processes, including bioreactors, chromatography, UF/DF, filtration, CIP/SIP, and clean utilities.
· Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles.
· Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support.
· Excellent communication, technical leadership, and cross-functional collaboration skills.
· Preferred certifications include ISA CAP, GAMP, Functional Safety, or relevant automation platform certifications.
Why Join Catalyx?
At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.
Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.
At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.
