Validation Engineer III

Athens, GA, US • Posted 30+ days ago • Updated 6 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Job Details

Skills

Technology Transfer
Continuous Improvement
Acquisition
Technical Support
Functional Requirements
URS
Regulatory Affairs
FRS
Training
Auditing
Inspection
Change Control
Corrective And Preventive Action
Manufacturing
Leadership
GMP
Regulatory Compliance
Communication
Distribution
Biology
Documentation
Management
Microsoft Excel
Microsoft Outlook
Microsoft PowerPoint
Science

Summary

Roles & Responsibilities:

Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment.
Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures.
Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement.
Train personnel in quality and validation principles.
Support Engineering and other departments in the selection, review, acquisition, and upgrade of systems and production equipment.
Provide technical support in developing user and functional requirements specifications (URS, RA, FRS, DQ) for systems and equipment.
Act as Lead Validation representative on assigned project teams; communicate new requirements and perform training with Validation team to assure timelines are met for successful project completion and product launches.
Share quality philosophies throughout Operations and support Production and Engineering.
Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies.
Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready" at all times.
Execute actions required to support Change Control, Deviation, and CAPA on-time closure.

Education & Experience :

Minimum 6 years GMP validation or similar experience in a GMP manufacturing/production environment.
Minimum 10 years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
At least 3 years leading projects.
Ability to plan, schedule, organize, prioritize, and coordinate project activities.
Ability to function in a leadership role and within cross-functional teams.
Ability to analyze validation and production data to assess compliance with GMP requirements and troubleshoot compliance problems.
Excellent written and verbal communication skills.
Strong comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology).
Ability to make decisions regarding product acceptability based on documentation.
Demonstrated ability to work with diverse groups and manage conflict.
Proficiency in MS Word, Excel, Outlook, and PowerPoint.
Bachelor's degree, preferably in a science or engineering-related field.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: ee753fd9cf953de96e64636f33f73b7
Posted 30+ days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Engineer III, Validation

Greenville, North Carolina

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office 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 car

Full-time

Senior Automation Engineer

Cornelia, Georgia

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

Infrastructure & Capital Projects - Construction Quantity Surveyor (Lead or Mid-Career), ANS

Atlanta, Georgia

•

Today

Opening from Default - All locations As Accenture continues to grow, we have an increasing number of career opportunities available to you. Depending on the job and location, you may be directed to apply with Accenture Infrastructure & Capital Projects LLP or one of the following Legal entities: * Accenture Infrastructure and Capital Projects, LLC * Accenture Infrastructure and Capital Projects Inc. Please note that benefits can vary by country and role. Please check with your recruiter for

Full-time

USD 125,000.00 - 160,000.00 per year

Board Validation Engineer

Duluth, Georgia

•

Today

Please Note: 1. If you are a first time user, please create your candidate login account before you apply for a job. (Click Sign In > Create Account) 2. If you already have a Candidate Account, please Sign-In before you apply. Job Description: The Board Validation Engineer validates products against technical requirements. Design, develop, and implement validation procedures to evaluate the reliability of designs. Perform signal analysis and standardized compliance tests. Areas of test focus

Full-time

USD 91,000.00 - 146,000.00 per year

Search all similar jobs