QC & Microbiology Analytical Lead – Sampling & Method Transfer

PROCESS ENGINEERING SPECIALISTS PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

PES International is seeking a QC/Microbiology Analytical Lead to join our life sciences projects in Singapore. You will lead QC analytical and microbiology sampling activities, ensuring alignment with GMP milestones and project timelines.

You will provide technical leadership across analytical QC and microbiological testing, coordinate with CQV, Validation, Manufacturing, and Quality teams, and ensure readiness of equipment, methods and documentation for commissioning and start-up.

Qualifications

• Experience in QC analytical and microbiology testing within pharma/biopharma.
• Experience with new facilities, technology transfer or major capital projects.
• Strong knowledge of cGMP and data integrity principles.
• Ability to lead sampling strategies and coordinate with cross-functional teams.

Responsibilities

• Lead all QC analytical and microbiology sampling activities to meet project milestones and GMP requirements.
• Develop and execute sampling strategies for process, utilities and environmental monitoring, including cleaning validation and qualification/validation activities.
• Provide technical leadership across analytical QC and microbiological testing, including method transfer, verification and validation.
• Coordinate sampling and testing with CQV, Validation, Manufacturing, Engineering, MSAT and Quality teams.
• Ensure laboratory readiness: equipment, methods, documentation, consumables, sample management and testing capacity.
• Lead planning and coordination of sampling/testing during commissioning, qualification, PPQ and start-up.
• Review data and support resolution of OOS/OOT, deviations, investigations and CAPAs.
• Ensure sampling, testing and documentation comply with cGMP and regulatory requirements.
• Identify risks and drive resolution to protect project schedule and readiness.

Skills

QC Analytical

Microbiology

GMP Compliance

Data Integrity

Job description

PES International is seeking a QC/Microbiology Analytical Lead to join our life sciences projects in Singapore. You will lead QC analytical and microbiology sampling activities, ensuring alignment with GMP milestones and project timelines.

You will provide technical leadership across analytical QC and microbiological testing, coordinate with CQV, Validation, Manufacturing, and Quality teams, and ensure readiness of equipment, methods and documentation for commissioning and start-up.