QC Lab Equipment Engineer/Field Service Engineer - Tuas

WuXi Chemistry; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading chemistry organization in Singapore seeks a qualified individual to manage laboratory instruments, ensure compliance with industry regulations, and effectively communicate with stakeholders in both English and Chinese. Candidates should possess over three years of relevant experience and a degree in a related field. Responsibilities include maintenance of instruments, drafting procedures, and participation in audits.

Qualifications

• Over 3 years of experience in management of analytical instruments.
• Experience in GMP instrument management is preferred.
• Familiar with technical specifications for analytical instruments.

Responsibilities

• Select, purchase, install, and maintain laboratory instruments.
• Draft procedures and ensure compliance with regulatory documents.
• Participate in audits and inspections to ensure GMP compliance.

Skills

Pharmaceutical production understanding

GMP regulations familiarity

Proficient in English and Chinese

Analytical testing proficiency

Project management skills

Good computer skills

Detail-oriented

Strong coordination and communication

Education

Bachelor's degree in Engineering, Pharmaceutical, or Chemistry

Job description

Responsibilities

• Responsible for the selection/purchase, installation/commissioning, validation/calibration, maintenance, and repair of QC laboratory instruments
• Draft various procedures and technical documents related to instruments, participate in the maintenance and optimization of processes, and ensure their implementation;
• Conduct laboratory events and deviation investigations related to instrument management
• Initiate changes related to instrument management and track the timely execution of CAPA
• Assist analysts in troubleshooting during testing, and provide training on relevant skills when necessary
• Evaluate data integrity of various instrument systems and improve the department's level of data integrity
• Proactively study regulatory documents from various countries, such as CP, USP, JP, and EP, and refer to these documents when updating internal procedures
• Participate in customer audits and government inspections, promptly address identified issues, and ensure GMP compliance
• Timely track work progress, strengthen communication with internal and external clients, and establish stable and good relationships
• Assist department leaders in building a high-efficiency team.
• Perform any other ad hoc duties and responsibilities assigned by the Department Lead.

Requirements

• Engineering, Pharmaceutical or Chemistry related major, bachelor\'s degree or above
• Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations
• Prior experience in instrumentation companies (e.g., Agilent, Waters, Thermo Fisher, etc.) is strongly preferred.
• Proficient in English and Chinese, fluent in spoken English and Chinese to liaise with stakeholders from China and overseas, to support technical transfer.
• Good computer skills.
• Over 3 years of work experience in the management of analytical instruments; candidates with GMP instrument management experience will be given priority
• Proficient in analytical testing and quality management, familiar with the structure and working principles of analytical instruments
• Familiar with industry laws and regulations regarding technical specifications for analytical instruments
• Familiar with industry requirements for data integrity of analytical software; candidates with experience in computerized systems validation will be given priority
• Strong ability to handle on-site issues, with good coordination, communication and execution skills
• Detail-oriented, proactive and able to work under pressure
• Ability to determine problems, gather information, understand facts and draw correct and effective conclusions through scientific reasoning
• Project management and tracking skills
• Ability to manage budgets and assets, controlling lab expenses
• This role required an on-the job training in China for approximately 3 to 6 months.