Vacancy expired!
Please note that this is a 1 year contract position. Summary:Supports all areas of Validation including product and process validation, equipment qualification (including continued process verification) and software and spreadsheet validation. Authors, reviews, executes and investigates all site validations and associated documentation.DUTIES AND RESPONSIBILITIES:• Authors, reviews and/or approves validation documentation including protocols, reports and other sources of information to ensure that validations and procedures are consistent with current industry standards and Regulatory requirements.• Authors, executes, and reviews of Validation plans, IOQ and PQ protocols, final reports to support manufacturing operations and equipment, laboratory equipment, and production processes within a strictly regulated facility.• Temperature mapping and other activities to support the facility's continuous process verification program.• Support changes required for continuous improvement initiatives and change management throughout plant operations.• Ensures that validation and qualification activities are consistent with company validation policies and procedures.• Demonstrates a basic understanding of the Product Engineering and Quality Management System concepts.• Proceeds according to the company's quality policy in all business activities with providers and customers within and outside the company. • Exhibits a basic understanding of statistical process controls (SPC),the DMAIC process and other quality and manufacturing investigative tools.• Experience in working with cross-functional teams, including technical and non-technical work. • Ability to organize and present technical information with minimal assistance.• Provides training and guidance on aspects of validations and qualifications.• Support the Quality system and Change Management processes.• Participates in cross functional meetings related to changes in processes and products, process improvements and implementation of corrective actions. • Contributes to the development, implementation and execution of quality systems in support of design and developmental studies.• Supports Quality Engineers as needed by documenting and investigating nonconformance events and supporting root cause investigations (RCI) and CAPA.• Participates in internal and external audits which may include all areas of support and audit readiness tasks.  • Archival of validation documentation following company record retention procedures.• Maintenance and calibration of validation equipment (to be performed by outside vendor).• Tracks and trends quality data for management review. May also include presentation of data to a large group.QUALIFICATIONS:   • BA/BS Required , preferred to be in relevant technical discipline.• Experience in a cGMP/FDA licensed facility preferred.• Experience in one or more of the following areas preferred:• Computer/Software/Systems• Biomedical Engineering/Mechanical Engineering/Automation• Medical Technology/Biology/Chemistry or associated science• Experience in Medical Device, Pharmaceuticals, Life Sciences or Laboratory systems processes / projects• Must be Quality-minded, detail-oriented and possess excellent writing skills.• 3 to 5 years experience Applicants must provide their phone number. Reference job number A921.
Vacancy expired!