Validation Engineer

Job Description:

The Validation Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects the person in this role will work with other experienced members of the validation team to identify road blocks and additional efficiencies. Additional day to day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions.

Key Accountabilities:

-Execute all responsibilities as the validation owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency.

•Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs •Oversee all validation lifecycle activities

•Mentor valuation specialists

•Revise and maintain CGT validation SOPs

•Demonstrate a thorough understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Qualification (IQ)

Qualifications:

• Bachelor's Degree in Science or other related field
• 5+ years of relevant experience
• 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
• Experience with Quality Systems including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
• Ability to prioritize tasks as needed to support the changing business demands.
• Excellent technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
• Manager's Signature and DateEmployee's Signature (optional Employee ID) and Date