At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Part of the Microbiology/ Environmental Monitoring (EM) team responsible for the following:

Test EM / product stream samples to meet release timelines, in accordance with cGMP regulations and Roche standards
Support manufacturing operations with timely completion of testing and disposition
Continuous improvement of processes and technology, in collaboration with ASAT, to drive right first time and efficiencies
Qualification and validation of test methods
Support investigations of microbial contamination in production processes, classified environments and critical utility systems
Ensure test methods and data are generated in a cGMP, compliant manner

The Opportunity:

Technical:

Understand basic microbiological principles (Bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET)
Test and review routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM)
Perform EM, including HVAC/ BSC/ HLFH/ VLFH sampling, fingertips monitoring, compressed gases and water/ clean steam sampling in accordance to cGMP procedures
Document and review results in the Laboratory Information Management System (LIMS) and/ or documents in accordance to cGMP procedures
Review routine data and logbooks
Prepare trend graph for product lot release and trend data analysis

Functional:

Perform sample receipt, Chain of Custody and storage of QC samples
Manage life-cycle process for retain and reserve/ reference samples
Managed and prepare shipment of samples to Receiving labs
General lab support including housekeeping, document archival, maintaining logbooks and inventory of lab supplies, etc
Initiate discrepancy record

Others functional:

Ensuring timely completion of training required to support/ perform cGMP activities
Raise Work Notifications, follow-up on planned receipt, delivery orders, invoices, etc
Participate in process improvement works
Contribute to continuous improvement of laboratory procedures and processes to ensure compliance to cGMPs
Participates in internal/ external audits and regulatory inspections

Teamwork:

Cooperates with the Head of Microbiology Operations, QC Ops Lead and teammates to create an environment with strong team spirit
Strive towards team's objectives/goals
Demonstrates initiative and proactively turn ideas into action — to make things happen
Engage in proactive measures to promote a positive safety culture and follows applicable Safety, Health and Environment requirements
Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset
Good team player with willingness to cover other colleagues in continued support of the Micro/EM operations

Safety, Health & Environment:

Comply with all RSTO's Safety, Health & Environmental (SHE) requirements
Observe all RSTO's site security measures at all times

Lean Production System:

Embody PT Lean Production System (LPS), with a continuous improvement mindset and behaviors

Who You Are

Degree holder with little or no prior relevant work experience
cGMP standards and laboratory safety procedures
A collaborative and proactive team player
Good verbal and written communication skills in English

Preferred

Willing to work at Singapore Tuas Bay Link (Company shuttle bus is provided)
Must be able to work weekends, off-shifts and overtime as required

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

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