Quality Engineer

Job Title: Quality Engineer

Location: Onsite / Hybrid Columbus, OH

Client: Large Life Sciences Company

Start Date: ASAP

Duration: 1-year contractor with possibility of extension

• Identify and create effective process control systems to support the development of the qualification deliverables.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving validation quality incidents.
• Manage the quality validation activities of the workstream assigned.
• Review and approve validation deliverables like: change records, DQ documents (SIA, URS, FRS, DS, TM, and FMEA and risk assessment), IQ, OQ, ES,PQ,PV,CV and variations.
• Act as a liaison between Engineering, Div Quality Engineers, and Quality Systems, plant/division/Corporate, on all incidents or topics related to Pegasus validation systems of the workstream assigned.
• Participate in or lead teams in supporting validation quality disciplines, decisions, and practices.
• Escalate to the Validation Governance validation topics requiring clarification or further guidance.
• Participate as an active member of the Validation Review Board (VRB).
• Coach and guide the workstream team through the validation lifecycle phases of the Pegasus project.
• Foster a culture of GOOD Engineering Practices (GEP), Food Safety, U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, and compliance standards, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.