The Process Engineer for Validation is responsible for leading the validation activities for the Manufacturing Engineering team. The primary scope of work will be creating test methods, conducting product and process tests to demonstrate the proper qualification. Outputs of the qualifications activities will be to achieve standardized methods for the Management of Change of new and existing products, processes, tooling, and equipment for life science, single-use applications. This role typically participates as a team member for Technology Transfer/New Product Introduction projects starting during the Industrialization phase and works through and until the change or transfer is complete into the Commercialization phase. Key responsibilities of this role is to work with R&D, Designers, tool room, Application Development Engineering, Manufacturing Engineering, Quality Assurance and Production using site Validation Master Plan to align and/or perform validations using IQ/OQ/PQ, PFMEA and Control Plans to give proper work standards for released products and processes into production.
· Work independently using knowledge of current package designs, materials, industry requirements, and processes to drive revenue growth, cost savings, and efficiency gains that consider customer and plant requirements.
· Demonstrate packaging knowledge through building prototypes, testing, and validation of the developed design for customer approval and manufacturability.
· Support and/or drive productivity initiatives on packaging by working with the suppliers, procurement, and manufacturing teams.
· Utilize Engineering Change Order process to direct and govern project deliverables, risk assessment oversight and analysis.
· Ensure process, equipment, tooling and parts meet internal and customer requirements.
· Change leader for areas of responsibility for engineering standards for existing or newly validated parts.
· Participates and assists in process risk assessments through FMEA, part family control plans creation and updates.
· Participates and assists in root cause analysis with Quality Assurance, Manufacturing Engineering and Production in customer complaints.
In all work individual will promote a safe working environment, complies with proper use of PPE, reports incidents, and participates in functional department safety meetings. Exhibits good environmental practices and procedures consistent with job(s) performed and EMS (Environmental Management System) requirements.
· Bachelor of Science in an Engineering discipline required.
· Bachelor of Science in Mechanical, Biomedical, Chemical Engineering, or Technology preferred.
· 2-5 years of relative experience (Co-op or full time) required.
· Good work ethic, efficient, and willingness to safely perform required quality work with good attendance and attitude required.
· Proficiency with a manufacturing software system (preferably QAD), accurate data entry, and follow through required.
· Working knowledge of Microsoft Office, Microsoft Project, AutoCAD, and SolidWorks required.
· Demonstrated analytical skills, hands-on approach, proactive safety approach, and sense of urgency in problem solving required.
· Competencies of effective communication with all levels of the organization, suppliers, and customers managing multiple priorities and strong organizational skills.
· Work closely with cross functional teams including customers and outside vendors to identify, plan and implement continuous improvement projects to gain efficiencies while maintaining customer agreements.
· Maintain standard packaging family standards using FMEA, Control Plans, Standard Operating Procedures, Manufacturing Operating Procedures and Validated Engineering Standards to support Validation Master Plan while maintaining baselines for future quoting, part build and inclusion of new parts.
· Change Order (CO), and Design Transfer Checklist (DTC), risk assessment oversight and analysis including management of process deviations, and determination of customer notifications.
· Create, plan, coordinate and execute OQ Protocols, review, analysis and summary reports for new equipment. Determine, coordinate and execute physical package testing to ensure product and package integrity. Writes and performs test protocols for evaluations and validation.
· Determine, coordinate and execute physical package testing to ensure product and package integrity. Create, plan, coordinate and execute PQ Protocols, review, analysis and summary reports for evaluation for new process hand-off.
· Coordinate, direct and lead comprehensive Validation Master Plan (VMP) activities with associated IQ / OQ / PQ protocols, analysis and reports. Maintains appropriate validation documentation and files. Ensure packaging projects are in compliance with regulatory and corporate guidelines. Maintain compliance and knowledge of systems and procedures with the FDA regulations regarding package development.
· Implement CapEx improvements to automate and modernize equipment, processes, material handling.
Who are we ?
Saint-Gobain’s innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world’s leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life’s critical moments.
Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we’ve learned working together makes good ideas, great ones.
With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths.
Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you’re empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.
Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, 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.