Quality Validation Engineer

Saint-Gobain Corporation Clearwater , FL 33755

Posted 3 months ago

Position Description

Job Summary

If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.

We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.

Required Qualifications

Job Description

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.

Additional Description

Essential Functions

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.

Requirements

  • Bachelor's Degree in Engineering, Microbiology, Chemistry, or a related degree with scientific, engineering, clinical or regulatory course of study optimal. (Required)
  • Bachelor's Degree in Biology (Strongly Preferred)
  • Technical Certification/Training in HVAC Systems and Sterilization Sciences (Preferred)
  • Support of Sterility Assurance Program in Life Sciences Industries (5+ Years Minimum Experience)
  • Demonstrated Experience with Sterilization Guidance (EN ISo 11135, ISO 11137, EN285)
  • Medical Devices (Validation and routine control of devices)

EFR Part 820

  • ISO 13485

Company Summary

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.

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Invent yourself at Saint-Gobain Life Sciences; and together, we'll create a better life. Legal Statement Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans. Saint-Gobain Corporation Clearwater-ppl FL

Quality Validation Engineer

Saint-Gobain Corporation