Job Description

THE OPPORTUNITY

• Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide!
• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista\xe2\x80\x99s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

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.Quality Control (QC) Microbiology, is part of our Manufacturing Division, where we ensure that safe and efficacious medicines and consumer healthcare products are delivered to patients around the world every day through accurate and reliable testing services.WHAT YOU WILL DOAs part of the QC Microbiology team in Singapore, Microbiologists and Analysts also qualify competent employees to perform precise sampling to monitor the quality of the facility\'s critical systems, such as water systems and cleanrooms to meet pharmaceutical grade waters and classifications for its intended manufacturing use. The data generated from the laboratory is analyzed by the Microbiology department, and valuable in supporting the Manufacturing Division for decision making, and as sharing for other network sites to leverage on.This position reports to the Manager in the Microbiology Laboratory of the company Biotechnology Facility.Main responsibilities are as follows:

• Perform routine/ non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, water for Injection, Pure steam, Compressed air and Nitrogen systems.

• Perform routine/ non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test.

• Perform personnel qualification and re-qualification, lead qualification and re-qualification of the clean rooms, when necessary.

• Provide testing support to plant validation activities.

• Perform in-process and release sample 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 routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.

• Perform Media receival, Sterility check and Growth Promotion Tests for media used in testing.

• Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.

• Perform Microbial identification (Bacteria, mold and yeast) in water, environment and product samples.

• Perform periodic reviews.

• Writing/ revision of SOPs, protocols, test reports and any other work assigned by the Senior/ Lead Microbiologist, Senior/ Manager, Microbiology

• Liaise with external vendors on instrument calibration and maintenance.

• Solicit quotations of laboratory consumables.

• Maintain continuous supply of laboratory consumables.

• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.

• Supervise and oversee Third Party Contractors, where applicable

• Coordinate with Quality, respective Plant Operations, Projects and Engineering & Maintenance.

• Liaise with other department for training needs and technical support.

• Liaise with vendor and service engineers for equipment validation, calibration and maintenance work.

• Coordinate with suppliers of microbiological media and other equipment.

• Any other duties assigned by the Manager.

WHAT YOU SHOULD HAVEQualifications:

• Degree in Microbiology / Science (general) / related Engineering field

Required Skills / Experience / Competencies:

• Good understanding of Safety and cGMP practices

• Computer Literacy

• Good oral and written communication skills

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

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that\xe2\x80\x99s committed to delivering a high quality, reliable supply to customers and patients on time, every time.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 12/12/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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