QC Lab Equipment Engineer

STA PHARMACEUTICAL SINGAPORE PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a professional to manage QC laboratory instruments. The role involves selection, maintenance, and compliance with GMP regulations. Candidates should have a relevant degree, over 3 years of experience, and proficiency in English and Chinese. This position may require on-the-job training in China for 3 to 6 months.

Qualifications

• Engineering, Pharmaceutical or Chemistry related major, bachelor's degree or above.
• Understand pharmaceutical production, testing, and quality management.
• Over 3 years of work experience in the management of analytical instruments.

Responsibilities

• Select/purchase, install, validate, calibrate, maintain, and repair QC laboratory instruments.
• Draft procedures and participate in process optimization.
• Conduct laboratory events and deviation investigations.

Skills

Engineering

Pharmaceutical knowledge

GMP regulations

Analytical testing

Project management

Data integrity understanding

Communication skills

Education

Bachelor's degree in Engineering, Pharmaceutical or Chemistry

Tools

Analytical instruments

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.
• 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 (CSV) 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.