Validation Engineer

Overview

On Site
Full Time

Skills

Attention to detail
Microsoft Office
Project planning
Technical writing
Job boards
IMPACT
Science
SAFE
Specification
Pharmaceutics
Manufacturing
Documentation
Quality assurance
Quality control
Metrology
Data
Utilities
Chemicals
Mechanical engineering
Communication
Collaboration
Management
Innovation
Research
SAP BASIS
Accessibility

Job Details

Job Description

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 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:
  • 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.


Keys to Success:
Education
  • Bachelor of Science in Engineering field (Chemical, Mechanical, or related) required.
Experience
  • 1+ years of experience in engineering and validation in Pharmaceutical or Food and Beverage industry is preferred.

Knowledge, Skills, Abilities
  • 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

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! ;/b>

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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.