EngineerScientist II, QC

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll 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 youll support HPLC and analytical testing method validation and product/process sustainment activities. Youll 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 remuneration annual incentive plan bonus scheme healthcare company 401k and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform critical job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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