Job Description

Job Title: Engineer I, Validation
Requisition ID: 149243BR

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

How will you make an impact?

The Validation Engineer I will report directly to the CQV Manager, and will be part of a team in a biopharmaceutical contract manufacturing and development organization (CDMO) responsible for commissioning and qualification of facility, utilities and equipment used in drug substance and drug product manufacturing, quality control laboratories, and associated support areas like Automation and computer system at Thermo Fisher Scientific at the Alachua, FL site. Job specific activities shall include quality, safety, and conduct-based training that is crucial to operations in a cGMP facility. Additional and more specialized training will be assigned as appropriate or needed.

What will you do?

* Provide Validation support for ongoing Commissioning and Qualification projects including: Facility, Utilities and Equipment, instrument calibration review, troubleshooting technical issues, and supporting overall project objectives.
* Generate and execute Validation life cycle documentation such as Systems Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) Validation Summary Reports, and Deviations reports for Manufacturing and process Equipment & Utilities as per Thermo Fisher guidelines.
* Analyze and interpret validation test data to determine whether systems or processes have met validation criteria or to identify root causes of deviations.
* Oversee vendor personnel who perform qualifications and calibrations services. Witness and review qualification documentation for the installation and delivery of new equipment. Provide Facilities review of certificates and qualifications performed by outside vendors.
* Utilize a Kaye Validator AVS including Sim setup, Pre- and Post-calibration of Thermocouples. Use of software applications including Kaye Validator Software and ValPro.
* Performs other duties as assigned.

How will you get here?

Education

High School Diploma/GED required

Technical Degree w/ 2 years' validation experience preferred or B.S. Degree in Engineering w/ 2 years' validation experience preferred

Experience

* Two (2) years2019 experience in a pharmaceutical GMP environment. Minimum of two (2) years direct validation experience.
* Candidates with other technical bachelor2019s degrees will be considered if they have two (2) or more years of direct validation experience.
* Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
* Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.
* Experience with the qualification of single use technology is desired.
* Experience with Kaye Validator Software 2000, Kaye AVS2019s and ValPro2019 s.

Knowledge, Skills, Abilities

* Familiarity with the pharmaceutical industry or other regulated industry, proficient in the use of computerized office applications (e.g. Word, Excel), project management and demonstrated technical writing skills.
* Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
* Strong interpersonal and communication skills
* Ability to lift up to 50 pounds.

Work Hours: Monday to Friday, 8:00AM to 5:00PM 40Hrs per week. Overtime on evenings and weekend may be required to meet project deadlines.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.