QC/Microbiology Analytical Lead-Sampling/Method Transfer-BioPharma

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

We are currently looking for a QC/Microbiology Analytical Lead to join us on a permanent role to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities

• Lead all QC analytical and microbiology sampling activities for the new project, ensuring alignment with project milestones and GMP requirements.
• Develop and execute sampling strategies for process, utilities, water/WFI, environmental monitoring, cleaning validation and qualification/validation activities.
• Provide technical leadership across both analytical QC and microbiological testing, including method transfer, verification and validation.
• Coordinate sampling and testing requirements with CQV, Validation, Manufacturing, Engineering, MSAT and Quality teams.
• Ensure laboratory readiness, including equipment, methods, documentation, consumables, sample management and testing capacity.
• Lead planning and coordination of sampling/testing during commissioning, qualification, PPQ and start-up.
• Review analytical and microbiological data and support resolution of OOS/OOT, deviations, investigations and CAPAs.
• Ensure all sampling, testing and documentation comply with cGMP, data integrity and applicable regulatory requirements.
• Identify sampling/testing risks and constraints and drive timely resolution to protect the overall project schedule and operational readiness.
• Require strong pharmaceutical/biopharmaceutical experience across both QC Analytical and Microbiology, ideally within a new facility, technology transfer or major capital project environment.

We are currently looking for candidates in Singapore.

If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Sruthi Srikanth ([email protected]).

If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: https://www.linkedin.com/company/processengineeringspecialists/mycompany/

PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.