Listing Description

VALIDATION ENGINEER - REMOTE
(CYBERSECURITY SYSTEMS)

Seeking experienced Validation Engineers with a proven track record in computer system validation. The ideal candidate would like to expand their skills within an enterprise biopharma organization remotely. This role supports a very wide variety of computer systems, including Kneat, which will increase your capability to secure other projects in the future. It is 100% remote for our client in Pennsylvania and Maryland.

This role supports the execution of cutting-edge projects. Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits. Develops and executes qualification protocols and final summary reports and may participate in commissioning activities.

SKILLS AND EXPERIENCE

• Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems


• Siemens Desigo BAS, and Werum PAS|X MES experience is highly preferred, but will also consider computer system validation experience with MS Dynamics ERP, Kneat, and Labware LIMS


• Experience with automation, commissioning, qualification or operations in a cGMP environment of one (or more) of the following systems:




• Cybersecurity




• Direct experience developing validation protocols and execution of protocols.


• Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.


• Experience with the commissioning and qualification of automation and related systems within virtual and production cGMP environments.


• Experience creating validation master plans and performing risk assessments.


• Knowledge of current industry standards such as GAMP5 and ASTM E2500.

BENEFITS