Validation Engineer III

Athens, GA, US • Posted 3 hours ago • Updated 3 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 3 hours ago

Create job alert

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

Validation Engineer III

Dice Job Match Score™

Job Details

Skills

Summary

Similar Jobs