Engineer/Scientist I, QC

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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

Position Summary

As an Engineer/Scientist I, QC, you are part of a hard-working team dedicated to delivering world-class solutions in the pharmaceutical and medical device industry. 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

LIMS

• Closely collaborate with the LIMS implementation team to deploy and implement various modules (e.g. environmental monitoring, sample login and receipt, sample testing, test methods, specifications, simple instruments connections, etc), ensuring flawless performance and adherence to timelines.

• Prepare and complete comprehensive test cases to ensure the successful implementation of LIMS modules.

• Develop and update local SOPs and training materials as required.

• Provide LIMS training to end users.

• Troubleshoot and resolve project issues in collaboration with the LIMS implementation team.

• Perform timely and accurate LIMS data maintenance to support NPI and business needs

GENERAL

• Conduct qualifications of new laboratory systems.

• Lead and perform deviation analysis from laboratory systems, ensuring root cause analysis and effective CAPA implementation.

• Ensure timely maintenance and calibration of laboratory equipment.

• Accurately set up static data and manage user access for laboratory systems.

• Conduct comprehensive impact assessments of change controls and update documentation promptly.

• Author detailed laboratory procedures.

• Conduct effective training sessions for personnel on laboratory systems.

• Apply cGMP and data integrity principles in all areas of work.

• Foster a “Quality Culture” and support the company’s 4i values within QC.

• Participate in internal and external audits to ensure GxP and regulatory compliance.

• Lead and support Practical Process Improvement Initiatives to drive continuous improvement.

• Perform ad-hoc activities as assigned by the business.

• Follow emergency procedures and safe systems of work.

• Ensure compliance with environmental, health, safety, and security policies at all times.

• Report and investigate all accidents, near misses, and breaches of rules promptly.

Minimum Requirements/Qualifications

• This is a fixed term role

• Degree in chemistry, biochemistry, life sciences, or a closely related scientific field.

• Minimum 2 years of experience in a pharmaceutical or medical device industry laboratory.

• Proven knowledge of regulatory expectations including PICS, ICH, EMA, and US FDA.

• Experience with equipment and IT systems such as CDS, LIMS, and OneMaximo.

• Strong proficiency in English, both oral and written.

• Basic proficiency in Microsoft Word, Excel, and PowerPoint.

• Logical thinking with excellent attention to detail.

• Ability to work independently and meet critical timelines.

• Self-motivated with outstanding problem-solving and time management skills.

Thermo Fisher Scientific believes that each employee has a valuable story to share. Join us in our mission to enable our customers to make the world a better place. Apply today and be a part of our story.