- Develop commissioning and qualification lifecycle documentation.
- Advise functional departments on the creation of user and system specifications and requirements, as well as reviewing/approving these documents.
- Complete protocols while coordinating with Validation personnel, Manufacturing, QA, QC, Facilities, Metrology and Engineering departments to assure expeditious and accurate completion per agreed upon project plan.
- Summarize and evaluate protocol data, including resolution of discrepancies and exceptions as required for completion of validation summary reports.
- Perform periodic reviews or re-qualifications to maintain validation status of equipment, instruments, facilities, utilities and computer systems as defined by approved validation SOPs.
- Author and/or revise SOPs as necessary.
- Bachelor of Science in Engineering field (Chemical, Mechanical, or related) required.
- 1+ years of experience in engineering and validation in Pharmaceutical or Food and Beverage industry is preferred.
- Strong technical writing skills, accuracy, attention to detail, and integrity
- Excellent communication skills and an ability to effectively collaborate with others to achieve team goals and expectations
- Self-starter with an ability to work in a fast-paced environment and to effectively manage time and prioritize work
- Experience with pharmaceutical manufacturing equipment and processes
- Basic understanding of GMPs
- Proficiency in Microsoft Office applications
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Validation Engineer - Union, United States - Thermo Fisher Scientific
Description
Job DescriptionAs 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 Specification Information:
Our Cincinnati site is a Center of Excellence for specialized oral solid dose pharmaceutical drug manufacturing and drug development as part of the Drug Product Division within our Pharma Services Group at Thermo Fisher Scientific. When you join our team, you will have the opportunity to impact the lives of patients and their families worldwide.
Discover Impactful Work:
The Validation Engineer is responsible for equipment, computer system, and facility qualification projects and the execution of commissioning and validation documents for our pharmaceutical manufacturing and packaging equipment and systems in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs.
A Day in the Life:
Education
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