Tech Service Specialist I

ThermoFisher Scientific; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific in Singapore is seeking a QC Technical Services Specialist II to support the operation, validation and maintenance of laboratory systems in line with GxP expectations.

Reporting to the QC Manager Technical Services, you will lead qualification activities, prepare protocols and collaborate with lab personnel, IT and vendors to ensure equipment is calibrated, validated and compliant, driving a culture of quality and continuous improvement.

Qualifications

• Degree in Chemistry or related scientific field is required.
• Experience applying GMP and regulatory expectations is preferred.
• Strong attention to detail and ability to follow complex procedures.
• Ability to work independently and meet critical timelines.
• Familiarity with LIMS/CDS and analytical equipment is beneficial.

Responsibilities

• Lead qualification of new equipment and lab systems per regulatory expectations and 21 CFR Part 11.
• Support implementation of laboratory systems.
• Prepare technical documentation including qualification protocols and reports, SOPs and investigations.
• Work with stakeholders to maintain and calibrate QC lab facilities and equipment.
• Ensure maintenance and calibration are scheduled, performed and reviewed for accuracy and regulatory compliance.
• Provide administrative support for CDS, LIMS and lab equipment.
• Support lab investigations as SME.
• Coach colleagues on lab systems and equipment.
• Participate in Process Improvement initiatives in the lab.
• Support a Quality Culture and 4i values.
• Ensure cGMP is applied and align with cGMP across business.
• Work compliantly and adopt EHS, cGMP and 5S mindset.
• Undertake ad-hoc activities.
• Participate in audits to ensure GxP compliance.
• Conduct internal audits and ensure compliance with cGxP.

Skills

Independent working

Attention to detail

Organisational skills

Timely delivery

Education

Degree in Chemistry or strongly related scientific field

Tools

LIMS

CDS

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Position Summary:

Reporting to the QC Manager Technical Services.

DESCRIPTION:

Join our Quality Control team at Thermo Fisher Scientific where you'll make meaningful contributions to our mission of enabling customers to make the world healthier, cleaner and safer. As a QC Technical Services Specialist II, this role is responsible for supporting the effective operations of all laboratory systems and equipment to ensure that they are validated, calibrated and maintained in line with the current GxP and regulatory expectations.

Responsibilities:

• Lead, perform and support qualification of new equipment and lab systems according to regulatory expectations and in compliance with FDA 21 CFR Part 11 compliance.

• Support implementation of laboratory systems.

• Prepare technical documentation including but not limited to qualification protocols and reports, standard operating procedures and investigations.

• Work collaboratively with all stakeholders (e.g. lab personnel, global lab solution team, IT and vendors) to ensure QC lab facilities, utilities, system and equipment are maintained and calibrated in accordance to regulatory expectations

• Ensure that equipment maintenance and calibration are scheduled timely, performed and reviewed for accuracy, completeness and in compliance with regulatory expectations and documented procedures.

• Provide administrative support for Chromatography Data System (CDS), Laboratory Information Management System (LIMS) and laboratory equipment.

• Support lab investigation related to lab system and equipment as SME.

• Coach colleagues with knowledge of lab system and equipment.

• Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab

• Support and encourage a “Quality Culture” and company 4i values throughout QC

• Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.

• Work compliantly and adopt EHS, cGMP and 5S mindset.

• Undertake ad-hoc activities that may be required by business.

• Participate and support in the preparation of site audits, customer audits and regulatory audits to ensure GxP and regulatory compliance.

• Conduct internal audits and ensure compliance with cGxP and regulatory requirements.

EH&S:

• Understand emergency procedures and adhere to safe systems of work.

• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times

• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

Minimum Requirements/Qualifications:

• Degree in Chemistry or strongly related scientific field

• At least 1 to 2 years of relevant industrial experience (preferably in the pharmaceutical or medical devices industry)

• Ability to apply GMP regulations and other international guidelines to all aspects of the position.

• Basic knowledge of cGxP/regulatory expectations/PICS/ICH requirements

• Basic knowledge of LIMS, CDS, analytical equipment capabilities and operational needs

• Ability to work independently and adhere to critical timelines

• Excellent attention to detail

• Excellent organisational skills, including ability to follow assignments through to completion

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.