Validation Engineer

CSV Engineer LVL IV

Job Location: Portsmouth, NH Job Duration: 10 months on W2

The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. Specialist will be involved as the QA CSV representative during small and large-scale projects.

Perform all aspects of QMS process' – Change Control, Deviations, CAPAs

Execute all responsibilities as CSV project lead for complex projects

Oversee all CSV lifecycle activities

Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives

Mentor junior specialists

Revise and maintain CSV SOPs

Assess departments standing in the business and regulatory aspects

Function as CSV SME in Inspections and Audits

Perform other duties as assigned.

Computer Systems Validation 5-10 years (Required)

Adherence to cGMPs is required at all times during the manufacture of drug products.

All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects and related actions.

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.

Must comply with safety policies of the company and site

Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.

Strong written and oral communication skills.

Strong organizational and time management skills

Bachelor's Degree in Computer Science / Software Engineering (required)

English (Required)