LIMS & Data Integrity Specialist

Bachem Holding AG

California

On-site

USD 88,000 - 123,000

Full time

13 hours ago
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Benefits offered by this job

Competitive pay
Annual performance bonus
Medical/Dental/Vision coverage
401(k) plan with employer contribution
Paid vacation, personal and sick days

Job summary

Bachem Americas is seeking a LIMS Administrator to configure and maintain the Laboratory Information Management System, ensuring data integrity and regulatory compliance. You will work with QC analysts and IT to optimize workflows and support validation activities.

The role requires hands-on LIMS experience, CSV validation, and proficiency with SQL reporting. This position offers a competitive package and exposure to global regulatory standards within a fast-paced biotech environment.

Qualifications

  • Bachelor’s degree in life sciences or other relevant discipline.
  • 3+ years of experience with LIMS platforms (e.g., LabWare, STARLIMS, LabVantage) Req and
  • Hands-on experience with analytical software used in QC labs (Chromeleon, Empower, etc.) and integrating such systems 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.
  • Familiarity with pharmaceutical/biotech laboratory workflows (release testing, stability, method validation).
  • Knowledge of integration with ERP or ELN systems.
  • Experience leading or supporting system upgrade or enhancement projects.
  • Strong background in QC operations and analytical instrumentation.

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 associated 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–related issues; provide training and guidance to end users.
  • Integrate LIMS with laboratory instrumentation and QC software (e.g., Chromeleon, Empower) to streamline workflows and ensure data integrity.
  • Develop, review, and maintain documentation (e.g., 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 and reviews to identify issues, ensure compliance, and recommend improvements.
  • Monitor equipment/software performance, coordinate calibrations and preventive maintenance, and support resolution of system-related issues.
  • Benchmark best practices, identify trends, and contribute to continuous improvement of laboratory data management systems.

Skills

LIMS administration
CSV validation
GxP/GMP knowledge
SQL and data reporting
Analytical software integration
Documentation (URS/OQ/PQ/SOPs)
Project upgrades experience
Communication skills

Education

Bachelor’s degree in life sciences

Tools

LabWare
STARLIMS
LabVantage
Chromeleon
Empower

Job description

Bachem Americas is seeking a LIMS Administrator to configure and maintain the Laboratory Information Management System, ensuring data integrity and regulatory compliance. You will work with QC analysts and IT to optimize workflows and support validation activities.

The role requires hands-on LIMS experience, CSV validation, and proficiency with SQL reporting. This position offers a competitive package and exposure to global regulatory standards within a fast-paced biotech environment.

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