Engineer​/Scientist II, QC

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Laboratory Setting, Office, 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.

LOCATION
:
On-site Bedford, MA. Relocation assistance is NOT provided.

• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

DESCRIPTION:

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. As an Engineer/Scientist II on our Quality team, you'll support HPLC and analytical testing, method validation, and product/process sustainment activities. You'll apply your expertise in analytical chemistry and chromatography to support QC projects, raw material characterization, stability studies, investigations, and continuous improvement while collaborating across Quality, Manufacturing, Engineering, and R&D teams.

This role offers excellent opportunities for professional growth while working alongside colleagues who share your commitment to science and quality.

What will you do?

• 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:

How will you get here?

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.

We offer competitive…