Laboratory System Related Validation Consultant (Mid-Level)

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Description:

Work consists of development and execution of System Life Cycle documentation for analytical systems and related software/database packages. Responsibilities include documentation development, lab system configuration, system testing, system troubleshooting, and Standard Operating Procedure (SOP) implementation. Examples of systems include (TOC, AA, UV-Vis, HPLC, GC, etc.)

External Responsibilities:

• Provide project-related task management activities for projects.
• Perform internal quality reviews of deliverables prior to submission to clients.
• Mitigate project issues.
• Provide technical expertise to members of the team as needed for projects.
• Identify new prospective clients and assist with the expansion of the core client base of Covex.
• Track existing project status; identify possible project issues and mitigate them.

Pre-requisites:

• Bachelor’s degree in related science (Biology, Chemistry, Biochemistry, Biomedical) or Chemical Engineering field required.
• 5+ years’ overall experience in a laboratory cGMP setting required.
• 3+ years’ experience in validation, qualification, or related compliance field.
• Strong understanding of System Development Life Cycle, 21 CFR Part 11 and Eudralex Annex 11
• Strong understanding of Data Integrity (ALCOA+ principles).
• Excellent writing skills; capable of adequately using Microsoft Office tools.
• Outgoing personality with strong oral and communication skills; demonstrated ability to work well with new peers.
• Ability to work in a team environment and be capable of delivering on critical client demands.
• Ability to travel by all modes of transportation; infrequent weekend travel maybe required.
• Sporadic 40+ hour work weeks.