Quality Engineer
1 week ago
Job Title: Quality Engineer
Location: Onsite/Hybrid Columbus, OH
Start Date: TBD
Duration: 1-year contract with possibility of extension
Responsibilities- 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.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
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