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

Thermo Fisher Scientific Pharmaceutical Services Group Indianapolis, Clinical Trial Division

How will you make an impact?

The Validation Engineer will be responsible for initial validation of equipment used in our clinical trial drug packaging processes. In addition, ongoing support in diagnosing and resolving software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network will be an important element of this role. Frequently, this effort requires collaboration with other site maintenance teams. The validation engineer will also communicate issue resolution summary to impacted area supervision. The Validation Engineer will also support after hour support calls as needed.

What will you do?

• Assessing and defining assigned validation projects.
• Writing, reviewing, and implementing project validation protocols for standard & customized systems.
• Raise discrepancies and closeout test documentation.
• Prepare validation summary reports for completed protocols
• Conduct deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.
• Resolve technical software, instrument, and process issues.

How will you get here?

Education

• BS in engineering or another scientific field.
• Equivalent combinations of education, training, and relevant work experience may be considered

Experience

• 2 years of hands-on validation experience with the development and execution of FAT, SAT, and IQ/OQ protocols.
• Execution of project qualification activities and closeout.
• Self-motivated and proactive with confirmed time-management skills
• Experience with DeltaV or similar automation system.
• Preferred experience in control systems testing, preferably within the biotech or pharmaceutical sector.

Knowledge, Skills, Abilities

• Good understanding of cGMP, GDP, and regulatory requirements for automated systems.
• Computer Systems Validation
• Attention to detail and ability to identify and remediate issues found during testing.
• Highly effective verbal and written skills, including technical authorship.
• Proficient in Microsoft Office, particularly Microsoft Word and Excel

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 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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