VALIDATION ENGINEER - REMOTE
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:
- 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.
- Citizenship: Not Provided
- Incentives: Not Provided
- Education: Not Provided
- Travel: Not Provided
- Telework: Not Provided