QC Microbiology Validation Specialist

Aphex Group; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Aphex Group seeks a QC Microbiology Validation Specialist to support New Product Introduction to QC Microbiology. The role provides hands-on testing for bioburden and bacterial endotoxin validation and ensures validation activities, documentation and data are planned, executed, reviewed and compliant with cGMP and data integrity requirements.

You will plan, perform and review validation protocols, test plans and summary reports, coordinate testing with QC Microbiology, Manufacturing, QA and

Qualifications

• Minimum of 5 years of experience in a cGMP Quality Control, microbiology or validation environment.
• Experience with bioburden and bacterial endotoxin testing, including validation or verification activities.
• Experience supporting New Product Introduction, method transfer, method validation or qualification within the pharmaceutical or biopharmaceutical industry.
• Good knowledge of current regulatory, pharmacopeial, cGMP and data integrity requirements relevant to QC Microbiology validation.
• Experience in Quality Risk Management, investigation techniques and technical report writing.
• Strong organisational and stakeholder-management skills, with the ability to coordinate testing and documentation to project timelines.
• Degree in Science, Microbiology or related discipline.

Responsibilities

• Support the planning, execution and completion of microbiological method validation, verification and qualification activities.
• Provide specialist support for New Product Introduction (NPI) and the development of QC Microbiology validation strategies.
• Author, review and execute validation protocols, test plans, data packages, summary reports and associated technical documentation.
• Perform routine and validation sample testing for bioburden and bacterial endotoxin in accordance with approved methods and procedures.
• Coordinate validation testing activities, sample requirements and documentation with QC Microbiology, Manufacturing, QA, Technical Transfer, Technical Services and project stakeholders.
• Ensure validation data and records are complete, accurate, traceable and compliant with cGMP and data integrity requirements.
• Investigate out-of-specification, out-of-limit and atypical results using Structured Problem Solving and Root Cause Analysis tools, and support effective corrective and preventative actions.
• Lead and participate in Quality Risk Assessments associated with microbiological methods, validation activities and NPI implementation.
• Perform technical review of laboratory data, validation protocols, worksheets and reports.
• Troubleshoot microbiological methods, equipment and validation execution issues, escalating risks and delays as appropriate.
• Track validation deliverables, actions, milestones and dependencies, and provide clear progress updates to QC Microbiology management and the project team.
• Support inspection and audit readiness by ensuring validation documentation is complete, controlled and readily retrievable.
• Represent QC Microbiology at project, validation, quality and technical meetings as required.
• Provide technical support to Manufacturing and project teams through validation testing, investigations, data assessment and preparation of technical reports.
• Identify and implement practical improvements that strengthen validation delivery, documentation quality and laboratory efficiency.
• Maintain current knowledge of relevant microbiological technologies, pharmacopeial expectations, regulatory requirements and site procedures.
• Provide technical guidance and training to laboratory personnel on approved validation methods, protocols and documentation requirements.
• Use approved AI tools to support processes, including data analysis, document development and result monitoring.

Skills

Bioburden testing

Endotoxin testing

cGMP

Data integrity

Problem solving

Regulatory knowledge

Stakeholder management

Documentation

Training guidance

Education

Bachelor's degree in Science/Microbiology

Tools

AI data analysis tools

Job description

Purpose:
The QC Microbiology Validation Specialist is responsible for supporting New Product Introduction (NPI) to QC Microbiology. The role will provide hands-on technical support for bioburden and bacterial endotoxin validation testing and associated GMP documentation, ensuring validation activities are planned, executed, reviewed and completed in line with approved project and quality requirements.

Responsibilities:

• Support the planning, execution and completion of microbiological method validation, verification and qualification activities.
• Provide specialist support for New Product Introduction (NPI) and the development of QC Microbiology validation strategies.
• Author, review and execute validation protocols, test plans, data packages, summary reports and associated technical documentation.
• Perform routine and validation sample testing for bioburden and bacterial endotoxin in accordance with approved methods and procedures.
• Coordinate validation testing activities, sample requirements and documentation with QC Microbiology, Manufacturing, QA, Technical Transfer, Technical Services and project stakeholders.
• Ensure validation data and records are complete, accurate, traceable and compliant with cGMP and data integrity requirements.
• Investigate out-of-specification, out-of-limit and atypical results using Structured Problem Solving and Root Cause Analysis tools, and support effective corrective and preventative actions.
• Lead and participate in Quality Risk Assessments associated with microbiological methods, validation activities and NPI implementation.
• Perform technical review of laboratory data, validation protocols, worksheets and reports.
• Troubleshoot microbiological methods, equipment and validation execution issues, escalating risks and delays as appropriate.
• Track validation deliverables, actions, milestones and dependencies, and provide clear progress updates to QC Microbiology management and the project team.
• Support inspection and audit readiness by ensuring validation documentation is complete, controlled and readily retrievable.
• Represent QC Microbiology at project, validation, quality and technical meetings as required.
• Provide technical support to Manufacturing and project teams through validation testing, investigations, data assessment and preparation of technical reports.
• Identify and implement practical improvements that strengthen validation delivery, documentation quality and laboratory efficiency.
• Maintain current knowledge of relevant microbiological technologies, pharmacopeial expectations, regulatory requirements and site procedures.
• Provide technical guidance and training to laboratory personnel on approved validation methods, protocols and documentation requirements.
• Use approved AI tools to support processes, including data analysis, document development and result monitoring.

Requirements

• Minimum of 5 years of experience in a cGMP Quality Control, microbiology or validation environment.
• Demonstrated experience in bioburden and bacterial endotoxin testing, including validation or verification activities.
• Experience supporting New Product Introduction, method transfer, method validation or qualification within the pharmaceutical or biopharmaceutical industry.
• Good knowledge of current regulatory, pharmacopeial, cGMP and data integrity requirements relevant to QC Microbiology validation.
• Experience in Quality Risk Management, investigation techniques and technical report writing.
• Strong organisational and stakeholder-management skills, with the ability to coordinate testing and documentation to project timelines.
• Degree in Science, Microbiology or a related scientific discipline.

Working Environment:
The duties of this role are generally conducted in a laboratory environment. As is typical of a laboratory-based role, employees must be able, with or without an accommodation, to lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; communicate in person as well as via phone, video and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; and maintain general availability during standard business hours.