LIMS Administrator – GMP & Data Integrity Lead

Bachem Holding AG; Vista (CA); On-site; USD 88,000 - 123,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k) match

Paid vacation

Sick/Personal days

Job summary

Bachem Americas is seeking a LIMS Administrator to configure, maintain, and support the LIMS platform, interfacing with QC workflows and enterprise systems to ensure data integrity and regulatory compliance.

The role collaborates with QC analysts, IT, and QA to meet GxP, GMP, and FDA standards, and involves system validation, master data management, and user support. Base salary ranges are provided, reflecting education and experience.

Qualifications

• Bachelor’s degree in life sciences or related discipline.
• 3+ years of experience with LIMS platforms (LabWare, STARLIMS, LabVantage).
• Hands-on experience with analytical software used in QC labs (Chromeleon, Empower) and integrating with LIMS.
• Strong understanding of GxP, GMP, and FDA regulatory requirements in a QC laboratory environment.
• Experience with computer system validation (CSV), including documentation and audit readiness.
• Proficiency in SQL, data management, and report generation.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Responsibilities

• Administer, configure, and maintain the LIMS platform, including upgrades, troubleshooting, and performance optimization.
• Collaborate with QC analysts, IT, and QA to ensure LIMS and related systems comply with GxP, GMP, and FDA regulations.
• Configure and manage master data, workflows, and user accounts within LIMS.
• Support laboratory staff with LIMS- and instrument-software issues; provide training to end users.
• Integrate LIMS with laboratory instrumentation and QC software to streamline workflows and ensure data integrity.
• Develop, review, and maintain documentation (URS, OQ, PQ, SOPs, policies, protocols).
• Participate in system validation, change control, and audit readiness activities.
• Create and manage reporting formats, queries, and data analysis tools (SQL, custom reports).
• Conduct periodic audits to identify issues, ensure compliance, and suggest improvements.
• Monitor equipment/software performance, coordinate calibrations and preventive maintenance.

Skills

LIMS experience

SQL & reporting

GxP/GMP/FDA knowledge

Problem solving

Communication

Independent work

Education

Bachelor’s degree in life sciences or related

Tools

LabWare

STARLIMS

LabVantage

Chromeleon

Empower

Job description

Bachem Americas is seeking a LIMS Administrator to configure, maintain, and support the LIMS platform, interfacing with QC workflows and enterprise systems to ensure data integrity and regulatory compliance.

The role collaborates with QC analysts, IT, and QA to meet GxP, GMP, and FDA standards, and involves system validation, master data management, and user support. Base salary ranges are provided, reflecting education and experience.