Systems Engineer

Catalyx • Malvern, PA

47d

About The Position

Catalyx is seeking experienced Systems Engineer to support / upgrade laboratory systems operating within regulated GLP and GMP environments.
Key Responsibilities
· Execute Windows 11 upgrades on business-critical laboratory and manufacturing PCs
· Perform system assessments to determine compatibility and upgrade readiness
· Support validation activities in GLP/GMP-regulated environments
· Develop and execute test protocols (IQ/OQ support as required)
· Coordinate with Lab IT, QA, Automation, and site stakeholders
· Minimize operational disruption during upgrade execution
· Support rollback and remediation plans if required
· Ensure cybersecurity and data integrity standards are maintained
· Participate in change control processes and deviation management

Requirements

• 5+ years of IT infrastructure or endpoint engineering experience
• Direct experience supporting systems in GLP, GMP, or GxP regulated environments
• Experience with Windows OS migrations (Windows 10 to Windows 11 preferred)
• Familiarity with validated systems and computer system validation (CSV)
• Understanding of 21 CFR Part 11, data integrity, and audit trail requirements
• Experience supporting laboratory instrumentation PCs (analytical systems preferred)
• Strong documentation skills in regulated environments
• Experience working with Change Control systems

Nice To Haves

• Experience supporting pharmaceutical or biotechnology companies
• Exposure to validated lab applications (e.g., chromatography systems, LIMS, Empower, etc.)
• Knowledge of manufacturing systems (MES, SCADA, DCS interfaces)
• Familiarity with SCCM, Intune, or enterprise deployment tools
• Experience in regulated packaging or manufacturing environments

Responsibilities

• Execute Windows 11 upgrades on business-critical laboratory and manufacturing PCs
• Perform system assessments to determine compatibility and upgrade readiness
• Support validation activities in GLP/GMP-regulated environments
• Develop and execute test protocols (IQ/OQ support as required)
• Coordinate with Lab IT, QA, Automation, and site stakeholders
• Minimize operational disruption during upgrade execution
• Support rollback and remediation plans if required
• Ensure cybersecurity and data integrity standards are maintained
• Participate in change control processes and deviation management

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed