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Continuous Improvement Senior Process Engineer - Vaccine

Swiftwater, Pennsylvania

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"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

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Manage Sr. Engineer Continuous Improvement - Swiftwater, PA

The role of the Manager Sr. Process Engineer involves identifying, gaining consensus, and resolving safety, compliance, and efficiency issues that impact the Automated Visual Inspection in FFIP. This position actively contributes as a member of cross-functional teams, serving as an interface between the FFIP platform and the Technical Community. The Sr. Process Engineer is responsible for all activities related to the Continuous Improvement of Automated Visual Inspection for Drug Products. As an individual contributor within the organization, the role encompasses membership in cross-functional teams supporting FFaST (Focus Factory and Support Team) efforts, providing continuous improvement for the Factory with a focus on Automated Visual Inspection. Additionally, the Sr. Process Engineer provides project support for cross-functional teams, serving as the factory interface for addressing visual inspection and project-related issues.

Key Accountabilities:

  • Provides technical support/details for automated visual inspection to Engineering, Maintenance, Quality Assurance (QA), Quality Validation (QV) and Manufacturing Technology (M-Tech).

  • Proficient on Automated Visual Inspection recipe creation, tuning and troubleshooting for vials and syringes within the FFIP platform.

  • Responsible to train/mentor new and existing engineers on the visual inspection program that include recipe creation and tuning, troubleshooting and recipe management.

  • Provide daily support to shopfloor managers on visual inspection operations.

  • The ability to work independently or with other group to identify inspection issues, formulate solutions and implement changes as required.

  • Utilizing the "+QDCI" Visual Management Systems and working with the FFIP Management Committee to drive improvements in key metrics.

  • Ensure compliance with all regulatory requirements and good documentation are followed to provide a safe, quality, and effective product.

  • This position will support both the needs of production as well as project related activities.

  • The position will also require evaluation of automated visual inspection performance and finding ways to improve OEE and reduce false reject rate.

  • Having a strong working knowledge of the relationship between automated visual inspection tools, parameters, product characteristics and critical quality attributes

  • Coordinate project validation approach with P-tech, Engineering and Site Quality Operations.

  • Strong customer communication and the ability to work with multiple groups to complete projects for new and existing equipment within the Inspection department.

  • Responsible for the efficiency, and reliable operation of all automation visual inspection equipment.

  • This position will have interactions with Health, Safety and Environment (HSE), Engineering, Site Quality Operations, Information Technology & Solutions, Outside Contractors/Consultants, Vendors, Industrial Operations and Research & Development departments.

  • Providing technical coaching, training and guidance to inspection managers, maintenance personnel and junior engineers on visual inspection related subject matter.

  • Leading tactical responses to equipment related deviations, Agency observations, delivering technical solutions and communicating outcomes to site management.

  • Review/approve process design specifications, technical documents, validation project plans and assist on the execution of equipment validation.

  • Author / review / execute/ approve technical documents which support equipment recipe tuning.

  • Author Change Control which supports equipment, products related changes and project works.

  • Promote innovation to keep up to date with the latest regulatory expectations and industry standards.

Basic Qualifications:

  • B.S. in electrical, mechanical and/or other applicable engineering field required.

  • 1-3 years in pharmaceutical or biotech manufacturing, maintenance, and engineering experience.

  • Functional experience with machine vision and industrial machinery control.

  • An understanding of current pharmacopeia guidance and regulations regarding visual inspection is desired.

  • Requires 100% on-site present during normal workdays.

  • Willing to provide support during the off-shit hours occasionally that include remote or on-site.

  • Minimum of 2-years experiences working with automated equipment in a pharmaceutical cGMP or food industry environment or equivalent.

  • Experience in the areas of customer support, operational excellence, and troubleshooting.

  • Must have good written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams.

Manager Sr. Process Engineer FFast Continuous Improvement position is needed to support daily inspection operation activities and projects execution to alleviate equipment issues, process downtime, and improve the overall operation efficiency. This position will support the FFIP platform and functions as the Visual Inspection Engineer to interface between the Visual Inspection Operations and the Technical Community. Additionally, this position will provide technical coaching, training and guidance to inspection managers, maintenance personnel and junior engineers on visual inspection related issues.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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