Thermo Fisher Scientific

Quality Engineer

Thermo Fisher Scientific • $70K — $95K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or related field.
  • 4+ years of experience in equipment/process validation.
  • Experience with ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR.
  • Advanced proficiency in Microsoft Office Suite (Excel, Word).
  • Strong verbal and written communication skills.
  • Ability to work collaboratively across various functional areas.

Responsibilities

  • Oversee commissioning and qualification activities at the site.
  • Ensure compliance with Good Manufacturing Practices (GMP).
  • Lead or participate in quality improvement projects and policy revisions.
  • Review and approve Engineering and Maintenance documents.
  • Support development and qualification of new packaging processes and technologies.
  • Conduct FMEA assessments and develop corresponding documentation.
  • Play a key role in the Practical Process Improvement (PPI) program.

Benefits

  • Medical, Dental, & Vision benefits effective on Day 1.
  • Paid Time Off & Designated Paid Holidays.
  • Retirement Savings Plan.
  • Tuition Reimbursement.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Location/Division Specific Information

1223 West Morris Street, Indianapolis, IN - Pharma Services Group

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.

Day in the Life:
  • Applies Good Manufacturing Principles in all areas of responsibility.
  • Demonstrates and drives the Thermo Fisher values- Integrity, Intensity, Involvement and Innovation (The Four l'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, 00, and PO.
  • 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.


Keys to Success:
  • Minimum Bachelor's degree in Engineering field
  • Minimum of 4 years total experience required with equipment/process validation experience.
  • Equivalent combinations of education, training, and relevant work experience may be considered.
  • 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.
  • Proficiency with the English language.
  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 5-25 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.


Preferred Qualifications:
  • Experience with computer system validation is preferred.
  • Experience with quality system investigations, root cause analysis. and risk assessment tools preferred.


Excellent Benefits
  • Benefits & Total Rewards | Thermo Fisher Scientific
  • Medical, Dental, & Vision benefits-effective Day 1
  • Paid Time Off & Designated Paid Holidays
  • Retirement Savings Plan
  • Tuition Reimbursement

OTHER
  • Relocation assistance is NOT provided
  • Must be legally authorized to work in the United States now and in the future, without sponsorship.
  • Must be able to pass a comprehensive background check, which includes a drug screening

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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