Validation Consultant II

 

 

As Validation Consultant you will be working on-site within one of our specialized project teams. You will be responsible for the qualification of laboratory and manufacturing equipment and keeping that equipment in a current qualified state.

Tasks may include:

 

Initial qualification:

-          Support the client in preparing their part of the qualification. This includes the organization and coordination of kick-off and status meetings.

-         Preparation and execution of the qualification documents (Plans, Protocols, Reports, etc.) according to established procedures.

-         Perform Risk Analysis and apply Risk Mitigation strategies.

-         Support the client during the qualification, perform root-cause analysis, and identify corrective and preventive actions when appropriate.

Life-cycle support of laboratory instruments:

-         Review qualification and GMP documents

-         Develop re-qualification plans and protocols as required by change control

 

The candidate we are looking for:

 

• Has a minimum of 2 years experience in the pharmaceutical or medical devices industry, 4 – 6 years is preferred

·   Experience with qualification and FDA regulations (21 CFR Parts 11, 58, 210, 211, 820) is a bonus

• The candidate should be able to work independently, setting and making timelines and priorities • Should have a quality mind-set with attention to precision and accuracy• They must posses a masterful command of he English language

• Has a minimum of a BS in Chemistry, Engineering, or other scientifically related disciplines.  A M.S. is preferred.

 

What we offer

 

• Challenging projects in qualification and GMP compliance• Personalized training according to our internal quality system• Realistic career opportunities in an expanding and quality minded dynamic company• A competitive salary and benefits package