Sr. Validation Engineer Manufacturing
SAINT-GOBAIN PPL - portage, WI
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JOB REQUIREMENTS: Why do we need you ? If you want to 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. The Validation Engineer will provide support and guidance and execute the plan for validating equipment and processes to meet requirements for Life Sciences Systems. Will work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. While managing a team, will implement, maintain, and facilitate continuous quality improvement objectives, primarily cGMP and ISO 13485 for the plant. Key Accountabilities: Equipment and Process Validation: For both Portage and Poestenkill facilities. Writes and/or approves critical validation test document IQ/OQ/PQ or Process Validations as applicable. Manages the validation document approval process. Collects and interprets critical process and equipment data in support of test protocol development. Understands and develops process flow diagrams associated with equipment operation and manufacturing processes. Develops and maintains standard operating procedures in support of the validation and release of the process or system to manufacturing. Oversees and closely aligned with the execution of the validation testing per the approved test protocols. Ensures that the validation design outlined in the respective protocols is aligned with the respective risk assessment and statistical rationale for the process/ equipment under the scope of validation. Oversees measuring program generation, program modification, and associated validation activities required. Ensures compliance with software validation, process validations, equipment qualification, and test method validation procedures. 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. Oversees and executes facility and utilities... For full info follow application link. 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. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/A05677A2B50A4FC7
Created: 2024-10-21