Engineer/Scientist II, QC

at  Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
The QC Tech Services Specialist II position is an integral member of the Quality Control (Technical Services) team. In this role you will perform work required to ensure product laboratory systems are qualified and maintained at standards set forth by the Pharma Services Group (PSG), part of Thermo Fisher Scientific’s Quality System, mandated by regulatory agencies and clients requirements.

Key Responsibilities :

• Lead qualification of new laboratory systems.
• Lead and perform deviation arising from laboratory systems and ensure root cause analysis with effective CAPA to minimize reoccurrence.
• Ensure that laboratory equipment are maintained and calibrated timely.
• Ensure static data are setup accurately and user access management for laboratory systems (e.g. CDS, LIMS, OneMaximo)
• Ensure impact assessment of change control are adequately assessed and impacted documentation are updated timely.
• Author laboratory procedures.
• Conduct effective training for personnel on laboratory systems
• Ensure cGMP and data integrity principles are applied in their area of work.
• Support and encourage a “Quality Culture” and company 4i values throughout QC.
• Participate and support in the preparation of internal and external audits to ensure GxP and regulatory compliance.
• Lead and support company’s Practical Process Improvement Initiatives (PPI) to build a culture of outstanding performance and continuous improvement
• Undertake ad-hoc activities assigned by business.
• Understand emergency procedures and follow safe systems of work.
• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
• Ensure timely reporting and investigation of all accidents, near misses and breaches of rules

Minimum Requirements/Qualifications :

• Degree in chemistry, biochemistry, life-sciences or strongly related scientific field with minimum experience of 3 years in pharmaceutical or medical devices industry laboratory
• Knowledge of regulatory expectations including PICS, ICH, Singapore HSA, EMA and US FDA
• Experience in equipment and IT system (CDS, LIMS, OneMaximo)
• Strong English language proficiency skills, both oral and written.
• Basic proficiencies in Microsoft Word, Excel, Powerpoint
• Good knowledge of PICS/ICH/FDA/EMA/HSA regulatory requirements
• Logical thinking and excellent attention to detail
• Ability to work independently and follow critical timelines
• Self-motivated individual with excellent problem solving and time management skills

At Thermo Fisher Scientific, each one of our 75,000 outstanding 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.

• Lead qualification of new laboratory systems.
• Lead and perform deviation arising from laboratory systems and ensure root cause analysis with effective CAPA to minimize reoccurrence.
• Ensure that laboratory equipment are maintained and calibrated timely.
• Ensure static data are setup accurately and user access management for laboratory systems (e.g. CDS, LIMS, OneMaximo)
• Ensure impact assessment of change control are adequately assessed and impacted documentation are updated timely.
• Author laboratory procedures.
• Conduct effective training for personnel on laboratory systems
• Ensure cGMP and data integrity principles are applied in their area of work.
• Support and encourage a “Quality Culture” and company 4i values throughout QC.
• Participate and support in the preparation of internal and external audits to ensure GxP and regulatory compliance.
• Lead and support company’s Practical Process Improvement Initiatives (PPI) to build a culture of outstanding performance and continuous improvement
• Undertake ad-hoc activities assigned by business.
• Understand emergency procedures and follow safe systems of work.
• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
• Ensure timely reporting and investigation of all accidents, near misses and breaches of rule