Analyst, Pharmaceutical Microbiology LIMS

SGS; High Peak; On-site; GBP 59,000 - 74,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Tuition reimbursement

Job summary

SGS in the United Kingdom seeks an Pharmaceutical Microbiology LIMS Analyst to translate microbiology processes into validated LabVantage LIMS solutions. You will configure, validate, and support LIMS workflows for sterility, bioburden, endotoxin, environmental monitoring and microbial identification.

Collaborate with QC Microbiology, QA, Validation and IT to drive compliant methods, participate in inspections, and ensure data integrity under GMP and 21 CFR Part 11.

Qualifications

• Bachelor's or Master's degree in Microbiology, Biology, Pharmaceutical Sciences, and/ or Biotechnology.
• Minimum 5+ years in a GMP pharmaceutical laboratory.
• Experience with USP/EP/JP/BP methods; sterility, bioburden, endotoxin, environmental monitoring, microbial ID, method suitability studies.
• Regulatory knowledge and data integrity understanding.

Responsibilities

• 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, testing, traceability, and qualification protocols.
• Ensure GMP, 21 CFR Part 11, data integrity and pharmacopoeial compliance.
• Collaborate with QC Microbiology, QA, Validation and IT to implement methods and enhancements.
• Support regulatory inspections, audits and computer system validation activities.
• Drive harmonization and standardization of microbiology methods across labs.
• Provide guidance, troubleshooting, training and ongoing support to LabVantage users.
• Configure test methods, specs, sampling plans, calculations, result-approval workflows, and stability processes per USP/EP/JP/BP/Annex 11.

Skills

LIMS knowledge

LabVantage LIMS

Test templates

Specifications

Sampling plans

Calculations

Stability workflows

Result entry & approvals

Regulatory knowledge

Education

Bachelor's or Master's in Microbiology/Biology/Pharmaceutical Sciences/Biotechnology

Tools

LabVantage LIMS

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.

• 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
  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.


• Regulatory knowledge
  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.
  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.

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

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.