Contamination Control/Sterility Assurance Specialist SME-BioPharma
Summary
Specialist ensures sterility and contamination control in pharmaceutical/biotech manufacturing, leading risk assessments, investigations, and compliance with GMP standards.
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 Contamination Control/Sterility Assurance Specialist SME to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.
Key Attributes/Responsibilities
- Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
- Lead contamination control activities as the Subject Matter Expert (SME) for assigned systems and processes.
- Conduct contamination control risk assessments and implement mitigation strategies to ensure product quality.
- Oversee contamination control performance, environmental monitoring trends, and recommend continuous improvements.
- Lead investigations into contamination events, perform root cause analysis, and implement effective CAPAs.
- Ensure compliance with GMP, sterility assurance requirements, and internal quality standards.
- Perform regular shopfloor walkthroughs to verify adherence to contamination control procedures and identify compliance gaps.
- Support validation activities by preparing and reviewing protocols, reports, and technical documentation.
- Collaborate with Manufacturing, Engineering, Quality, Validation, and Microbiology teams to drive operational excellence.
- Review contamination control data and provide technical recommendations based on trend analysis.
- Support regulatory inspections and maintain inspection readiness through strong technical and quality oversight.
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 Nelson Anthony (careers@pes-international.com).
To know more about the latest Jobs and Projects we are involved in, please follow us on LinkedIn at 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.