Here is the job description.
Location: Franklin Lakes, NJ
Start: They will be brought on as we find them – there is a large
need. The goal is to work up to a managed services arrangement.
Here is the client’s request:
As an associate reporting into IT, the incumbent will be required to work
collaboratively with across Global IT associates, Corporate Quality
Management and Corporate Regulatory Affairs on both the validation of new
systems as well as the improvement of existing IT Quality Processes and/or
In this highly visible role, the Validation Engineer will be required to
provide validation support and guidance on a variety of system validation
projects and production environment changes. Additionally, the incumbent
must be capable of identifying and communicating any FDA/ISO/SOX compliance
risks within existing IT work processes and/or existing production systems.
The incumbent MUST be a subject matter expert of the SDLC methods as they
relate to Computer System Validation, IT Quality Systems and Technology in
general. Scope of business applications to be potentially supported will
range across GMP, GCP and GLPregulatory areas. Scope of role is
additionally inclusive of both application and infrastructure validation
responsibilities. Further responsibilities include supporting and
maintaining the validated state of Validation Document Mgmt. tool set.
· Identify areas of compliance risk and approaches to address those
risks (systems, processes and practices)
· Manage & Track Corrective Actions to Audit Observations
· Validation of ERP SAP, Content Mgmt. System and Infrastructure
· BS / BA in Information Technology &/or Related Science field
· Must have a minimum of 3+ years System Validation & QA Experience
· Experience in working in the FDA/ISO regulated environment is a
· Capable of working independently and within a team
· SAP validation experience is highly preferred
· Computer System Validation experience is a must
· Understanding of Software Development Lifecycle Practices
· Strong communication and documentation abilities and very strong
Word and Excel. Excellent written and verbal communication skills and
critical thinking abilities are a must
(Oracle Apps & Sap)
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