Senior Analyst, Pharmaceutical Microbiology LIMS

ISPE International; Lincolnshire (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Professional growth opportunities

Paid time off

Job summary

SGS is seeking a Pharmaceutical Microbiology LIMS Analyst to translate lab microbiology processes into validated LabVantage LIMS solutions. You will design compliant workflows covering sterility, bioburden, endotoxin, environmental monitoring, and microbial identification while partnering with QC, QA, Validation, and IT teams.

You will lead system configuration, validation support, and regulatory compliance efforts (USP/EP/BP/JP; 21 CFR Part 11; data integrity).

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmaceutical Sciences, and/or Biotechnology.
• 5+ years of GMP pharmaceutical laboratory experience.
• Experience with USP, EP, JP, and BP methods; sterility testing; bioburden; endotoxin; environmental monitoring; microbial identification; and method suitability studies.

Responsibilities

• Configure and maintain LabVantage LIMS for pharmaceutical microbiology testing.
• Develop and support test templates, specifications, sampling plans, calculations, and approval workflows.
• Translate regulatory requirements into system configurations and functional specs.
• Support system validation activities including IQ/OQ/PQ and computer software assurance.
• Ensure GMP, 21 CFR Part 11, data integrity, and GDP compliance.
• Collaborate with QC Microbiology, QA, Validation, and IT for methods and enhancements.
• Support regulatory inspections, audits, and computer system validation activities.
• Harmonize microbiology methods and workflows across laboratories.
• Provide guidance, troubleshooting, and ongoing user support for LabVantage.

Skills

LIMS Knowledge

Regulatory knowledge

Project coordination

GMP familiarity

Analytical thinking

Education

Bachelors or Masters in Microbiology/Pharmaceutical Sciences/Biotechnology

Tools

LabVantage LIMS Application

Test templates

Specifications

Sampling plans

Calculations

Stability workflows

Results entry & approvals

Job description

Company Description

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

The Pharmaceutical Microbiology LIMS Analyst serves as the subject matter expert responsible for translating pharmaceutical microbiology laboratory processes into validated LabVantage LIMS solutions. This role combines deep knowledge of GMP microbiology testing with hands on experience configuring, validating, and supporting laboratory information management systems in regulated pharmaceutical environments.

The position partners quality control, microbiology, quality assurance, validation, and IT teams to design and implement compliant LIMS workflows supporting sterility, bioburden, endotoxin, environmental monitoring, microbial identification, and other microbiological testing programs.

The position partners quality control, microbiology, quality assurance, validation, and IT teams to design and implement compliant LIMS workflows supporting sterility, bioburden, endotoxin, environmental monitoring, microbial identification, and other microbiological testing programs.

• Configure and maintain LabVantage LIMS functionality for pharmaceutical microbiology testing.
• Develop and support test templates, specifications, sampling plans, calculations, and approval workflows.
• Translate laboratory and regulatory requirements into system configurations and functional specifications.
• Support system validation activities, including requirements documentation, testing, traceability, and qualification protocols.
• Ensure compliance with GMP, 21 CFR Part 11, data integrity principles, and global pharmacopoeial requirements.
• Collaborate with QC Microbiology, Quality Assurance, Validation, and IT teams to implement new methods and system enhancements.
• Support regulatory inspections, audits, and computer system validation activities.
• Drive the harmonization and standardization of microbiology methods and workflows across laboratories.
• Provide technical guidance, troubleshooting, training, and ongoing support to LabVantage users.
• Configure test methods, specifications, sampling plans, calculations, result-approval workflows, and stability processes in accordance with USP, EP, JP, BP, 21 CFR Part 11, Annex 11, data integrity principles, and good documentation practices.
• Implement LIMS test methods by gathering requirements, developing functional specifications, supporting system validation activities—including IQ, OQ, PQ, or computer software assurance—and ensuring solutions meet regulatory, operational, and business requirements.
• Serve as a key liaison between laboratory personnel and technical teams to standardize and harmonize microbiology processes across the organization while maintaining inspection readiness and regulatory compliance

Qualifications

Education and Experience

• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmaceutical Sciences, and/or Biotechnology
• 5+ years of experience in a GMP (Good Manufacturing Practices) pharmaceutical laboratory
• Experience with USP, EP, JP, and BP methods; sterility testing; bioburden; endotoxin; environmental monitoring; microbial identification; and method suitability studies.

Knowledge/ Skills/ Abilities

• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Laboratory Information Management System (LIMS) knowledge
  • LabVantage LIMS Application
  • Test templates
  • Specifications
  • Sampling plans
  • Calculations
  • Stability workflows
  • Result entry and approvals
• Regulatory knowledge
  • USP 71, 61, 62 and 85
  • 21 CFR Parts 11, 210, and 211
  • Data integrity principles (ALCOA+)
  • Good Documentations Practices (GDP)

Compensation

The expected salary range for this position is $80,000 – $100,000 annually. This range represents the minimum and maximum base salary we reasonably expect to pay for this role. Actual compensation within the range will depend on skills, experience, and qualifications.

Our Benefits

We care about your total well-being and will support you with the following subject to your location and role.

• Health: Medical, dental and vision insurance, life insurance, employee assistance programs.
• Wealth: In addition to base pay, we offer 401(k) with company match (immediate vesting upon enrollment).
• Happiness:
  • Professional Growth: Online training courses, virtual and classroom development experiences, tuition reimbursement program
  • Work-Life Balance: Paid-time off and family leave.

In compliance with applicable state and local pay transparency laws, we provide clear and equitable compensation information for all applicants.

Position anticipated to close November 1, 2026.

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression and Indigenous status, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada.