Validation Engineer

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. Summary: 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.

Job Title: CSV Engineer LVL IV
Job Location: Portsmouth, NH
Job Duration: 10 months on W2

Summary:

• 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.

Job Description:

• 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.

Requirements and Responsibilities:

• 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

Skills:

• 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

Education:

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

Language:

• English (Required)