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The Validation Engineer demonstrates quality in all actions. This position will directly support all validation work functions of the Clearwater/Largo Sites. The focus of Engineers within this job description, will be the support of large capital projects, and Technology Transfer projects (products and or processes) which include Facilities Validation, Utilities Validations, Product/Process Validations, Software and Equipment Validations. This candidate will provide critical aspects of the Validation work-function supporting the Clearwater/Largo sites in: requirements development, test protocol writing and approvals, all protocol executions, validation testing exceptions with root-cause investigations and resolution through corrective actions, and final validation report/ package compilation. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
Facility and Utilities Validation Programs:
Oversees and executed facility and Utilities validation activities in Operations settings.
Continually analyzes environmental and/or utility monitoring data from the manufacturing areas for purposes of remediation of any developing trends.
Ensures adherence of manufacturing activities to program requirements and regulatory expectations.
Ensures quality of product through observation/auditing, investigations, training and management of procedures.
SA objectives are achieved through this position's active involvement and leadership in SA / EM related deviations, procedure revisions, training programs, CAPA and Change control management systems, as well as through informal and formal auditing. In addition, this position helps ensure operations understanding of SA program through meetings and other means of communication.
Equipment and Process Validation:
Collects and can interpret critical process and equipment data in support of test protocol development
Understands and Develops process flow diagrams associated equipment operation and the manufacturing process
Develops Standard operating procedures in support of the release of the process or system to manufacturing
Writes critical validation test document IQ/OQ/PQ or Process Validations
Manages the validation document approval process
Executes the validation testing per the approved test protocols
Writes and manages approval of validation summary reports
Provides feedback to the plant leadership and project teams on best validation practices and approaches for project planning purposes
Quality Systems Support
This position will perform special projects as assigned as well as review relevant regulatory guidance in order to identify gaps within site programs and develop remediation strategy with functional leads.
Review change request documents.
Ensure compliance to Design Control Standard Practices, software validation, process validations and test method validation procedures with regards to sterility assurance processes.
Ensure that project and process development documentation are compliant with requirements and objectives. Review design, change specifications, and plan against process requirements.
Lead investigation on validation deviation and CAPA's as it relates to the assigned area of support.
Ensures compliance to all customers, QSR, cGMP, ISO 13485 and Medical Device Directive requirements.
Leads the site in performing risk analysis, root cause analysis of non-conforming product, in concert with other departments.
Identifies and recommends corrective and preventive actions resulting from product evaluation activities.
Ensures proper documentation of product field failures investigations to meet regulatory requirements and support non-conformance trending. Publishes QA reports of Quality activities per required frequency.
Provides Quality related training/education for site personnel.
Reviews and approve updates needed to product specifications.
EFR Part 820
Saint-Gobain Performance Plastics is one of seven businesses within the Innovative Materials Sector, which is spear-heading the advancement of innovation within the Group. Performance Plastics is a recognized leader in the advanced polymer technology market with access to state-of-the-art manufacturing and research & development facilities around the world.
Through close partnerships with our business leaders, our team works to support the achievement of business goals while emphasizing the PPL values of accountability, trust, initiative, respect and helping.