Validation Engineer

TRC's client, located in Atlanta, GA, has a direct hire opportunity for a Validation Engineer.
 
This position is with a Medical Device Manufacturing industry leader offering advancement opportunities, great culture and benefits!
 
The Validation Engineer be responsible for planning, coordinating and implementing qualification and validation activities for Equipment, process and System validation. This person will assist with Audits, ensure regulatory compliance, create customer declarations, etc.
Job Description
Independent planning, coordination and implementation of necessary qualification and validation activities related to all production and support processes including corresponding documentation
Validation activities during the projects including evaluation of test results and change/deviation management (e.g. for Production equipment, systems, software, peripherals, buildings and facilities etc.)
Monitoring of the required quality activities around the Validation activities (e.g. ordering test equipment, material qualification, supplier matters)
Creation of corresponding documentation according to the work instructions
Support and, if necessary, organization of risk management activities within the projects
Changes evaluation in terms of their impact on the qualified/validated state
Carry out requalification activities
Creation of customer declarations etc. (possibly in cooperation with others positions e.g. Regulatory Affairs)
Create and maintain test/sample sets
Support for internal audits, customer audits and if needed supplier audit
Contribution to new procedures, procedure updates and improvements (process descriptions work instructions)
Qualifications
Knowledge as typically acquired during at least 3 years of technical university studies (e.g. mechanical engineering, industrial engineering, or similar) and extended by at least 5 years of relevant professional experience in the areas of quality assurance, qualification and/or validation.
This function requires special knowledge in the areas of verification and validation of processes & qualification of equipment.
1-2 years of experience using project management methods
1-2 years of using statistical QM methods
1-2 years of experience working with IT applications (e.g. Office programs, MES, QM system)
Knowledge of quality management, QM methods and QM guidelines
Knowledge of problem-solving methods (e.g. KT)
Good technical understanding in dealing with specifications
Excellent analytical competence (especially in the field of interpretation of results and derivation of further measures)
Fluent in English
TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.