Total 2 Microbiologist job vacancies in Others category in The United States of America

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

QC Microbiology team in Singapore, as part of the company Biotech Facility performs quality monitoring of the facility's critical utility systems such as pharmaceutical grade water systems, environmental monitoring of classified cleanrooms for their intended usage in sterile drug product manufacture, in-process testing and final product microbiological release testing, as well as and analysis to support the Manufacturing Division for decision making / sharing for other network sites to leverage on.

What will you do

• Perform routine/non-routine quality monitoring and testing of utility systems and environmental monitoring of facility inclusive of Purified Water, Water for Injection, Pure steam, Compressed Gases, Classified Cleanrooms, Hygienic Areas and Laboratories.
• Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi-finished drug product and drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate
• Perform media receival, sterility check and Growth Promotion Tests for media used for testing, as well as culture maintenance, and microbial identification
• Documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports, and any other work assigned by the Senior, Lead Microbiologist, Sr/ Manager.
• Liaise with external vendors and suppliers on instrument calibration, maintenance, and laboratory consumables.

What you must have

• Degree in Life Science or related discipline
• 2 years of relevant working experience with good understanding of Safety and cGMP practices
• Proficient oral/written communication skills and digital literacy
• Analytical and problem-solving mindset is preferred
• Demonstrated inter-personal skills and team player

This is a career conversion programme under Workforce Singapore (WSG) and candidates must meet the following criteria and are open to the following conditions:

• Singaporeans/Singapore PRs only
• PMETs/Mid-Careerist with more than 2 years working experience (no prior work experience in Biopharma industry) are welcomed to apply
• Open to two years contract

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WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide

THE OPPORTUNITY:

As a Senior Specialist Operations Microbiologist, you will provide technical microbial and aseptic process support and expertise to the Sterile Integrated Process Team (IPT) in accordance to meeting the Priorities of: Compliance, Supply, Strategy and Profit Plan. You will be working closely and to provide technical solutions to the IPT team to support a High-Performance Organization. You will be an active member within the IPT Team providing support, guidance and striving for Aseptic excellence to ensure the success of the IPT.

WHAT YOU WILL DO:

Reporting to the Director Operations, you will provide ongoing coaching and support to the IPT team members, to share their aseptic technical knowledge and promote best practices, coaching on GMP requirements and regulations. Other responsibilities include:

• Leading IPT Micro Tier program
• IPT representative on Microbiological and aseptic processing technical agenda
• Member of Aseptic facility design and control teams, in areas such as HVAC design and application.
• Collaborates in the development and execution of the Facility-based Environmental Monitoring programs.
• Provides aseptic guidance on facility and process-related controls and changes.
• Handling of non-conforming EM/PM results, trend analysis
• Troubleshooting of suspected Microbiological Contamination incidents
• Participation in internal and external audits
• Responsible for the preparation, review and approval of relevant technical documentation, risk assessments etc.
• Ensure the highest Quality, Compliance and Safety standards.
• Participate and comply with our Quality Management System (QMS) requirements, related to QSIP implementation program for IPT.
• Carry out specific administrative tasks as instructed by the Senior Manager, Operations.
• Any other duties as and when assigned by the Manager.

In this role, you will drive continuous Improvements and responsible for driving a culture of Continuous Improvement by deploying our company's lean tools. You will also lead/participate in MPS related activities to instill continuous improvement mind set in the Operation Team. Besides, you are accountable for supporting all technical components of the process to deliver an effective and efficient IPT from an aseptic processing perspective.

ABOUT YOU:

To be successful in this role you should possess a Degree in Science/Quality or equivalent, with at least 3 to 10 years of experiences in Aseptic processing, Microbiology and pharmaceutical manufacturing. Other skill set include:

• Working knowledge of regulatory expectations of Aseptic processing in the Biotechnology industry.
  Strong analytical and technical skills.
• Demonstrated high level of problem solving and facilitation skills - resolution and prevention measures.
• Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application.
• Demonstrated self-motivation/direction skills with a continuous improvement focus.
• Demonstrated ability to lead and realise improvement initiatives.
• Demonstrated successes in a team environment, such as project teams, Six Sigma teams, Cl teams etc.
  Advanced PC skills such as Excel, Word, and Power point.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.