Digital Systems Specialist (Laboratory)

This is a critical role focused on digitizing GxP test method documentation. You will transition paper-based records to a digital platform, developing and configuring test method templates while ensuring full compliance with regulatory standards for analytical testing.

Key Responsibilities:

• Translate paper-based site analytical test methods into structured, configurable Digital Templates.
• Configure workflows, calculations, and data inputs to reflect site-specific Analytical Testing Processes.
• Execute rigorous User Acceptance Testing (UAT) and validation protocols to ensure Data Integrity.
• Collaborate with Quality Control (QC) Subject Matter Experts to secure formal Site Acceptance.
• Support LIMS, ERP master data builds, and equipment integration projects.
• Liaise between local laboratory users, Information Technology teams, and global enterprise application groups.

Essential Skills:

• 10+ years of professional experience with at least 2 years in an Analytical Testing Lab (Pharmaceutical, Biotech, or Cell and Gene Therapy).
• Direct experience implementing or upgrading digital systems (LIMS, ELN, QMS) in a GxP environment.
• Expert knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Proficiency in configuring web-based enterprise applications or database-driven systems.
• Strong documentation skills regarding configuration settings and validation results.

Desirable Skills:

• Experience in Cell and Gene Therapy manufacturing or testing.
• Familiarity with Equipment Integration and ERP configuration.
• Ability to perform tasks semi-independently and meet strict project deadlines.
• Strong risk identification and escalation management skills.