Equipment Validation Engineer

This position is for a validation Engineer that will be working on projects that will involve the deployment of machinery and data systems in a pharmaceutical regulated environment.

Deployments maybe for completely new technology unfamiliar to company or upgrades to existing equipment / systems. Position will report directly to a project manager but will be

Expected to work independently with other project teams members and departments. Engineer maybe on multiple project teams. Teams will be built with members from technical, quality, and end user department members.

Responsibilities :

• Validation engineer to support both equipment (blow-fill-seal machines) and data systems projects. Can have one or the other type of experience. Both would be a plus
• Ideal candidate should have 5+ years of experience writing validation documents like URS, SRS, and qualification protocols.
• Degreed engineer is preferred but open to candidates with a strong background with no degree
• Should ideally have experience in the pharmaceutical / sterile manufacturing industry, particularly with blow-fill-seal equipment validation.
• develop validation documents as needed. Documents will include the following :

▪ user requirement specifications / software requirement specifications

▪ validation master plans

▪ configuration specifications

▪ installation qualifications, operational qualifications, configuration qualification and performance qualifications.

▪ risk assessments for machinery and data systems in relation to compliance to 21 cfr part 11 compliance

▪ trackability matrices

▪ assistance in the generation of standard operational procedures for equipment validated.

▪ factory acceptance tests

▪ site acceptance tests

Supervision.

Education and experience requirement :

On experience in pharmaceutical industry and experience with machinery / data system Validations