What are the responsibilities and job description for the ENGINEERING / VALIDATION - Computer System Validation Engineer position at TPI Global (formerly Tech Providers, Inc.)?
Position : Project / Validation Engineer
Location : Libertyville, IL
Duration : 12 Months (Contract)
Job description :
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication
- Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
- Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.E. ServiceNow).
- Knowledge and exposure to Business Quality Management Systems (i.E. Veeva).
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Understanding of computer system validation.
- Familiarity with MES systems (i.E. Emerson Syncade), DCS systems (i.E. Emerson DeltaV, ERP systems (i.E. SAP or Oracle), EBRs (i.E. InfoBatch) and Historians (i.E. OSIsoft PI).
- Understanding of computer system validation (CSV).
Education and Experience :
