Shire Microbiologist I in Woodlands Industrial Park (Baxalta), Singapore
This position is involved in maintaining and optimizing Quality Systems in Microbiology/ Sterility Assurance Lab. In addition, this position is also required to perform routine microbiological testing using validated test methods and qualified instruments when required.
Lab Maintenance (System)
A Subject Matter Expect (SME) of Microbiological/ Sterility Assurance tests.
Lead and conduct method trainings to new lab personnel.
Initiate and investigate GEMS event via Trackwise system and Laboratory Investigation Report (LIR).
Participate in cross functional root cause analysis (RCA) during investigation.
Perform review and approval on QC test results.
Involve in audit preparation and ready to present during an inspection.
Lead a Lean Green Belt (LGB) project when tasked.
Lead a cost saving project when tasked.
Participate and perform method validation/ study when tasked.
Require to write different types of reports, such as trend report, technical or study report, memo, validation report, investigation report etc.
Revise Standard Operating Procedures (SOP) and EHS Risk Assessment.
Perform data compilation and trending on a monthly basis when required.
Have a good understanding on 5S methodology and able to transform an area using 5S methodology;
Vigilantly report/ highlight issues or unsafe act.
Ensure and maintain good housekeeping; ensure sufficient inventory to prevent any delays in testing.
Lab Maintenance (Instrument)
Perform preventive maintenance for laboratory equipment, such as Temperature Controlled Object (TCO), Biosafety Cabinet (BSC), etc.
Responsible for ownership of sophisticated lab equipment and conduct training to respective lab personnel.
Arrange equipment calibration with external vendor.
Manage and maintain service contract with vendor when required.
Perform peer review on equipment logbook.
Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT), Biological Indicator (BI) testing, microbial identification (ID), environment monitoring (EM), and plate reading.
Microbiological sample types include critical utilities, in-process/ Bulk Drug Substances (BDS), raw materials, investigational non-routine samples.
Perform sterilization cycle using qualified autoclave; perform depyrogenation using qualified cycle.
Perform aliquoting on Process and Non-Protein samples on a daily basis.
Support Lab Services team on replenishment of inventory from warehouse on a weekly basis.General Responsibilities
Responsibility to adhere to any applicable EHS requirements.
Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
Any other duties as assigned by supervisor.
Bachelor Degree in Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent, preferably with 1-2 years of experience in cGMP Pharmaceutical, Biopharmaceutical or related manufacturing environment and/ or related laboratory experience.
Diploma in Microbiology, Biological Sciences, Life Sciences, Biotechnology with minimal 6 years of related cGMP laboratory experience.
Experience in performing QC testing.
Preferably Experience in conducting microbiological study, investigation and cost saving projects etc.
Knowledgeable and expect of assigned subject matter.
Able to conduct training to new comer in an understandable manner.
Knowledge in cGMP quality system and industry guidelines e.g. GEMS, Change Control, release, documentation etc.
Organized and detailed oriented to drive completion of assigned tasks.
Able to solve problem with sound analytical thinking.
Able to propose ideas/ suggestion during a cross functional meeting or discussion.
Knowledge with Microsoft Office applications.
Knowledge of Safety principles, practices, regulations and procedure related to the work.
Mindset & Behavior
Committed to the role assigned.
Positive mindset and motivated.
Able to understand constraints at times and be flexible.
Good Interpersonal, Verbal and Written Communication Skills required.
Ability to work and collaborate within the team.
Mature and independent employee who require minimal guidance from QC Lead.
Good in emotional handling.
Good time management skills
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.