Engineer/Scientist II, QC

About the role

Join our Quality Control Analytical Development (QCAD) 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.

Responsibilities

• Perform HPLC and analytical testing to support engineering requests, manufacturing scale-up, raw material characterization, second sourcing, validation, and QC projects.
• Support method crossover validation, real-time stability studies, method transfer, continuous improvement, and other product/process sustainment activities.
• Collaborate with QC, Manufacturing, Engineering, and R&D teams to coordinate testing, validation, and method transfer activities.
• Participate in raw material characterization and second sourcing projects, including protein characterization and comparability assessments.
• Serve as an HPLC/chromatography technical resource for the Quality team, including method troubleshooting and improvement recommendations.
• Review analytical procedures, SOPs, test methods, and quality documents; support improvements related to compliance, method performance, and data integrity.
• Maintain accurate laboratory records and prepare technical reports, summaries, and presentations.
• Analyze and interpret data, including statistical analysis where appropriate, to support investigations, validations, and site quality initiatives.
• Maintain and troubleshoot laboratory equipment and instrumentation as needed.
• Support quality-related issues, investigations, and corrective actions in collaboration with cross-functional teams.
• Work independently and collaboratively while managing multiple priorities and project timelines.

Requirements

• Education/Experience: BS in Chemistry or related discipline with at least 2 years of experience in Analytical Chemistry, Molecular Biology, and/or HPLC.
• The ideal candidate must have strong relevant technical background.
• Experience with planning and executing experiments, data analysis and interpretation preferred.
• Experience with Protein purification and characterization and/or Ion-exchange Chromatography is a plus.
• Knowledge, Skills, Abilities:
• Strong knowledge of analytical chemistry, chromatography, analytical instrument qualification, and method execution in a laboratory environment.
• Experience with analytical techniques such as HPLC, spectroscopy, ELISA, protein characterization, or related instrumental methods; experience with additional techniques is a plus.
• Working knowledge of cGMP and/or ISO 13485 requirements, including CAPA, risk assessments, deviation investigations, and change control.
• Experience with statistical data analysis tools such as Minitab, JMP, or equivalent software.
• Ability to analyze data, troubleshoot technical issues, and apply scientific knowledge to new quality, validation, and process improvement challenges.
• Strong attention to detail, critical thinking, problem-solving, and organizational skills.
• Effective interpersonal and communication skills, including the ability to collaborate across teams and present technical information to internal and external audiences.
• Ability to work independently and collaboratively in a dynamic environment while managing changing priorities and maintaining a strong focus on quality.
• Basic understanding of continuous improvement practices such as Kaizen, Gemba, 3P, 5S, Standard Work, or similar lean tools.