Job Description

Job Title: Quality Engineer

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/Division Specific Information

Indianapolis, IN - Eli Lilly - Clinical Trials Division

How will you make an impact?

The Quality Engineer is responsible for providing oversight for commissioning and qualification activities at the site, as well as supporting equipment maintenance. In addition, this role supports ongoing quality initiatives and projects in alignment with Thermo Fisher values. Duties also include participating in internal and external audits, conducting FMEA assessments, and driving process improvement. Candidate must be an established quality system leader, strong communicator, and able to work with minimal direct oversight.

What will you do?

• Applies Good Manufacturing Principles in all areas of responsibility.
• Demonstrates and drives the Thermo Fisher values - Integrity, Intensity, Involvement and Innovation (The Four I’s).
• Responsible for ensuring GMP compliance and improving quality systems by leading or participating in projects, policy/procedure revisions.
• Review and approve Engineering and Maintenance documents inclusive of engineering studies, FAT/SAT, IQ, OQ, and PQ.
• Provide Quality support in the identification/development/qualification of new processes, featuring/tooling, and technologies into packaging operations.
• Support the development of test plans to ensure risk mitigation and quality requirements are met.
• Initiate and/or support in the development and/or update of Risk Management FMEA documentation in collaboration with multi-functional engineering teams per project requirements.
• Play an integral role in Practical Process Improvement (PPI) program.
• Works with FCS sites to assure consistency in validation strategy/approach for local and global projects.
• Conduct periodic self-inspections and participate in or internal, client and Regulatory inspections to assure cGMP requirements.
• Ensure that the Packaging facility and equipment are maintained in compliance with cGMPs.
• Conducts all activities in a safe and efficient manner.
• Able to partner with contacts at all levels of the organization. Additionally, periodic contact is required with the client in support of the FCS Validation Program, projects, presentations, tours, and capabilities.
• Strong attention to detail, collaboration, partnership, influencing, prioritization, decision-making, analytical problem solving, and verbal and written communication skills are required.
• Able to travel between sites, including international travel.
• Other duties may be assigned to meet business needs.

How will you get here?

Education:

• Minimum Bachelor’s degree in Engineering field
• Equivalent combinations of education, training, and relevant work experience may be considered.

Experience:

• Minimum of 5 years total experience required with equipment/process validation experience.
• Experience with computer system validation is preferred.
• Experience with quality system investigations, root cause analysis, and risk assessment tools preferred.

Knowledge, Skills, Abilities:

• Advanced experience with Microsoft Office Suite (Excel, Word, etc.) required.
• Ability to work with a variety of functional areas.
• Must be a self-starter, have excellent time management and organization skills, a high degree of work quality, attention to detail, and strong communication skills.
• Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing.
• Vision requirements for this position: Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or fewer), color vision, and the ability to adjust focus.
• Profiency with the English language.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

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